INVOcell- Analysis of Risk vs Benefit

November 11, 2014Carole 2 Comments »

Just the other day, I stumbled across an article published on Oct 24, 2014 that discussed a oral presentation presented at the recent ASRM meeting about a low cost IVF alternative called INVOcell. To my surprise, I found comments I made more than two years ago appearing in the current article although no one actually contacted me before they wrote the latest piece. So I thought I would revisit the issue, look at the new data and see whether I can learn to love INVOcell.

What is INVOcell?

INVOcell is IVF without the in-lab culture part. Like IVF, the INVOcell procedure has an ovarian stimulation cycle part to recruit eggs (check). An egg retrieval is performed  to get eggs (check). Eggs and sperm are put together (check), – in a plastic container which is placed in the vagina so the patient can vaginally incubate her gametes. (Whaat?= that’s the INVOCell part).  After 3-5 days, embryos are removed from the container and transferred back to the patient’s uterus.

So, back in 2011 I had two main concerns with this low cost alternative to IVF which I expressed in this post:

Invocell- not nearly IVF

Concern One. If eggs in cumulus and sperm are added to a small culture volume, these other cells will degrade the quality of the culture  medium as they incubate. That is why we remove these excess cells at fertilization check the next morning and place in fresh media. The newest version of the INVOCell technique uses either a very short co-incubation period for sperm and eggs with removal of excess cells before the egg goes into the container or ICSI to minimize the cellular material from the beginning to one egg with a sperm inside. Both of these are good solutions to the media degradation issue and so I am not worried about this any longer.

Concern Two: The fertilization check step is skipped. The window during which normal fertilization can be seen in the form of two pronuclear structures (2PN) inside the egg visible using a microscope happens during the time the egg is incubated in the INVOcell device inside the vagina- so obviously it doesn’t happen. The physician has the option to remove the vaginal device and open it, remove the embryos and check for fertilization but this is not routinely done. After all, the low cost part of INVOcell is due in part to the fact that you don’t do a lot of monitoring and checking during culture (reduced staff) , and don’t need to buy a lot of incubators (reduced equipment overhead since the patient brings her own vagina or that of a good friends to the case). I think INVOcell can be offered at half the price of regular IVF. The stim cycle drugs and physician/nurse time are still expensive but the lab expense can be minimal.

So what’s the big deal with skipping the fertilization check step? 

The reason we don’t skip this step in the IVF lab is because even abnormally fertilized eggs pretty routinely grow into very nice looking blastocysts which can’t make a normal baby but can make trouble if transferred- namely resulting in a molar pregnancy which is one of the complications under the category of gestational trophoblastic disease (GTD) .  Very rarely, a cancer (choriocarcinoma) can arise from GTD.

What causes the most common form of GTD ( hydatiform moles- aka.  molar pregnancies)  which can (rarely) result in choriocarcinomas?

Two types of fertilization errors cause GTD. First, an extra sperm enters the egg, resulting in a 3PN state, DNA from three gametes  (egg, sperm, sperm) instead of two (egg, sperm). Alternatively, the egg can fail to toss out its extra set of chromosomes before a single sperm gets inside- again you have DNA from three gamete sources (2 from the egg plus one sperm) causing a 3PN state instead of the normal 2PN state.

Can we tell if we have a normally fertilized egg or not and remove it from the pool of embryos eligible for transfer?

Yes, traditional IVF procedures require a “fertilization check” step to visually examine the fertilized egg under the microscope during a specific time period (16-20 hrs after sperm are added to the egg) to verify whether 2 pronuclei are visible (normal 2PN state) or more than two are visible (abnormal 3PN) state.

The INVOCell procedure does not include a check for 2PN status.

How often does gestational trophoblastic disease happen? From the American Cancer Society link:

Gestational trophoblastic disease (GTD) occurs in about 1 pregnancy out of 1,000 in the United States. Most of these are hydatidiform moles.

How often does GTD convert into a cancer? From the National Cancer Institute link:

The reported incidence of choriocarcinoma, the most aggressive form of GTD, in the United States is about 2 to 7 per 100,000 pregnancies. The U.S. age-standardized (1960 World Population Standard) incidence rate of choriocarcinoma is about 0.18 per 100,000 women between the ages of 15 years and 49 years.[2]

So the incidence of this across all pregnancies (natural and presumably some from IVF in this sample)  is relatively rare.

So why worry about GTD at all?

One reason I am not 100% relieved at this low incidence rate is that we don’t actually know what the rate of molar pregnancy is in IVF patients. I do know that in my experience, we could expect to have a least one molar pregnancy a year in our program.

What was the clinical outcome for IVF patients with a molar pregnancy? These patients had a D&C and then they were counseled not to attempt pregnancy for another 12 months just in case some of the cellular material was retained and could result in an undiagnosed choriocarcinoma. Molar pregnancy was a relatively infrequent event, but something that was treated very seriously when it happened.

There are various anecdotal reports of molar pregnancies in the published literature but I couldn’t find any  national statistics in the incidence of molar pregnancies arising from IVF. Yet, almost every program will, if asked, tell you that yes, they  have had IVF patients with molar pregnancies – and this is under regular IVF protocols in which  3PN embryos are routinely detected and removed from the groups of normal embryos for transfer.

So what can we expect if we skip this step? Will increased use of INVOcell unwittingly lead to the transfer of more abnormal 3PNs – some of which may implant and cause GTD?

Although we may not know the incidence of molar pregnancies in US IVF programs, I know that 3PNs are commonly present among the normally fertilized eggs of many of our patients. How do I know this? I know this because my lab would freeze these non-clinical embryos on a weekly basis (with patient permission) to use these as embryos for technical training. Techs could practice moving embryos from dish to dish or practice freezing or thawing them. We had 3PNs every week to freeze. We pulled them out of the clinical transfer pool but they were routinely arising in our culture system. They made great practice cells because they looked so normal.

So if we don’t look for them in the INVOcell system, does that mean they don’t happen?

My first post back in 2011- caused a big reaction on the part of a reader “Boris”. I took the bait and responded to him in a second, snarky post.INVOcell post strikes a nerve. It’s hard to tell who was suffering from more nerve pain- me or Boris.

In any case, more than two years after my last INVOcell post, earlier this month at the ASRM meeting in Honolulu, data from a small US study was presented that showed encouraging results with INVOcell compared side by side with regular IVF. You can decide if the new data warrants the exuberant headline from the  ASRM press release “Intravaginal incubation of embryos is safe and could save patients money.”

This new INVOcell study was presented by Dr. Kevin Doody from Bedford, Texas as an oral presentation at the meeting. The ASRM abstract data is presented below and  the entire abstract can be found at this link.  There’s not a lot there about how the INVOcell procedure was done except for this: “After a 2-4 hour co-incubation with sperm, up to 10 eggs were placed into the INVOcell device or into traditional incubators. After 5 days, one or two embryos were transferred into the uterus.” Since the window for fertilization check is after 16-20 hours, it’s probably correct to say that fertilization check step is still not part of the INVOcell procedure.

Incubator INVOcell
Number of cycles (patients) 16 17
Mean age 32.3 (26-38) 32.8 (26-38)
Mean body weight (pounds) 162.0 (121-207) 151.5 (109-184)
Mean number of oocytes inseminated 7.6 (1-10) 6.7 (3-10)
Mean number of embryos transferred 1.8 1.65
Mean blastocyst quality score (BQS) 27.24 26.14
Ongoing pregnancy rate /cycle 62.5% 58.8%

The patients in the study are fairly young (on average less than 35) and there were 16 patients in the Incubator method and 17 in the INVOcell method. Statistically speaking, 17 test patients is probably insufficient to detect the risk of GTD.

According to the Medscape article, another clinician, Dr. Lucena, in Bogota, Columbia says that she has seen no adverse outcomes in approximately 500 cycles, which while encouraging is probably still not enough cycles to detect an increased risk of GTD. It is also possible that other factors like advanced maternal age, may make a patient more prone to producing 3PN embryos. We just don’t know enough yet.

These early results are promising in that these patients had very comparable pregnancy rates between regular IVF and INVOcell. The FDA has not approved INVOcell yet for routine use in the US, but one INVOcell clinical trial(2011) is listed on the US government list of clinical trials.

I would be happier if we had more data and I would be ecstatic if we had some test to tell that these embryos are normal when they are removed from INVOcell culture and before they are used clinically. In theory,  genetic testing could be performed on INVOcell embryos but that would make INVOCell more expensive.

Is INVOcell safe? I don’t know. Most of the time when you drive around in a car without seat belts, no harm done. But sometimes, if you are unlucky, you can have preventable injuries if the car does crash. I would rather see more patients have access to insurance policies that pay for traditional IVF that has all the safety features, rather than encourage patients to use a cheaper procedure which may be riskier. Most patients will have no trouble but a few may have very bad trouble. In the end, it boils down to an analysis of risk vs. benefit. If you are enrolled in a clinical trial with INVOcell, hopefully the risk of GTD –as much as can be known- will be disclosed to you before you take part in a trial and you can decide:  Do you feel lucky?


Disclosure: As an ex- embryologist,  I have no financial interest in the performance of  EITHER regular IVF or INVOcell. As a patient advocate, I am always hoping for better infertility treatments and better access to these treatments for patients.

Egg freezing is no guarantee for future fertility

October 19, 2014Carole No Comments »

In 2013, the American Society for Reproductive Medicine (ASRM) declared that egg freezing was no longer experimental. Here is a link to the professional guidelines, which say in part: “There is good evidence that fertilization and pregnancy rates are similar to IVF/ICSI with fresh oocytes when vitrified/warmed oocytes are used as part of IVF/ICSI for young women. Although data are limited, no increase in chromosomal abnormalities, birth defects, and developmental deficits has been reported in the offspring born from cryopreserved oocytes when compared to pregnancies from conventional IVF/ICSI and the general population. Evidence indicates that oocyte vitrification and warming should no longer be considered experimental.”

I have highlighted some important caveats to this declaration.

  • The method of freezing makes a difference. Old-style slow freezing is not included because most US labs never demonstrated that slow egg freezing could repeatedly be performed with good results- although some Italian labs were successful with slow egg freezing. Vitrification is not considered experimental- when done expertly.
  • To get the best fertilization results, thawed eggs must be fertilized using ICSI (aka. egg injection) because the egg membranes harden and sperm in culture have a very difficult time pushing their way in to fertilize the egg; the sperm must be injected using a microscopic needle.
  • Outcome data are limited regarding whether the resulting offspring are normal but early results are encouraging.

If you read the entire document- which I strongly encourage you to do if you are thinking about egg freezing- you will notice that the authors raise the issue of generalizability of these results to all labs everywhere. The pregnancy data that was referenced was all from the frontier labs who took this method up as a major initiative in their lab and really worked hard to get those positive results. Even with vitrification, egg freezing is not an easy technique. It does not take long to do but in that short time between immersing an egg into toxic cryopreservation fluids, and plunging the container with the egg into liquid nitrogen, there are about twenty different ways to make a mistake and little or no time to fix it so you better be both fast and good at the hand work. That takes both excellent training and practice. This is made more complicated because there are about 10 different containers to freeze eggs in and various kinds of vitrification medium being produced by different companies all vying to tell labs that their method/media/container is the best. So it is not like there is one obvious best method that all labs can just get busy and learn to do well. There is no obvious best standard of care.

In one of my labs, we had great difficulty in reproducibly getting good results with vitrification even though our pregnancy rates with IVF and FET cycles were the best in the state. This is evidence that just because you have mastered one skill set, doesn’t mean that a new technique won’t require significant time and effort to master.  So when the “experimental” label was removed from egg freezing, my first reaction was dismay because I knew that a lot of clinics would recognize an opportunity to offer a new service –and make a lot of money–without necessarily making the investment in staff and training to do it expertly. A lot of first patients at these rush-to-offer egg freezing clinics would be guinea pigs who would happily pay their money and not know whether they had gotten any value for years.

So how are clinics doing? Nobody really knows- it’s not currently part of the data set that must be reported to the CDC- but that will change in the future.  Sure, good clinics are tracking their data internally now but until you thaw (warm) an egg and try to fertilize it and grow it to a blastocyst stage embryo for transfer, you have no idea whether the vitrification and warming worked and your egg is still alive and functional.  Women who are freezing for the future aren’t going to even try to use those eggs for years, so actually getting pregnancy data from vitrified eggs will be slow in coming– making it hard  today for patients to distinguish good egg freezing programs from bad egg freezing programs.

Now Apple and Facebook are covering egg freezing as a benefit for the employees. On the one hand, it is a great thing to remove barriers from reproduction for people who want to have kids. But the potential harm here is that women will think egg freezing is a slam dunk- and that by freezing eggs now, they have a guarantee that they will have functional eggs for producing a pregnancy in the future. I wouldn’t make that bet right now unless your program can prove to you that it has pregnancy outcome data from many, many patients who successfully used their vitrified eggs and are now happily raising these kids.

I know of at least one program that crowed about their success with achieving a single pregnancy from a vitrified egg but then failed to reproduce that event for another patient for months! Actually, I don’t know if they ever did have a second birth. They didn’t believe in writing down their methods so they couldn’t reproduce their success.  That didn’t stop them from aggressively marketing that first pregnancy using every social and media outlet they could find. I am sorry for all the women who went to that clinic based on one case. Yes, eggs were put in storage for the patients the marketing brought in, but there is no guarantee that they can rely on those eggs when they need them. And by the time those thaws happen in any real numbers and patients are unhappy, the greedy bastards who froze their eggs will have retired.

My advice to young women is that they should really push for pregnancy data from any clinic that wants to sell them egg freezing. Unless the clinic can document in writing that their birth rate for women of your age using frozen eggs are are no different than same-aged women using fresh eggs – AND- they have hundreds of successful pregnancies, not just one – don’t use their clinic. And don’t be fooled by their pregnancy data with embryo freezing. Embryo freezing is about 100 times easier than egg freezing so the success rates for one doesn’t necessarily translate into success rates for the other.

If your employer is paying for egg freezing, it’s a good idea to make sure your employer is also paying for annual storage fees and the IVF cycle(s) you’ll need in the future to actually use your frozen eggs.




Persistent Ebola virus detected in semen

October 11, 2014Carole No Comments »

We hear disturbing news about the Ebola outbreak in the media.  Ebola is a virus that is “difficult to spread” in the sense that we can’t just breathe the virus from the air, but actually need to touch someone who is sick and pick up the virus from contact with their bodily fluids (saliva, mucus, vomit, feces, sweat, tears, breast milk, urine, and semen). Surprisingly, the better known measles virus is one of the most contagious viruses around because on average, each measles patient infects 18 other people, compared to the average Ebola patient who infects two people. While meant to be reassuring, this type of statistic gives me little joy because we shake hands (and even hug) relative strangers every day- and have much more intimate physical contact with the people closest to us.

Well-run Andrology and Embryology (IVF) labs already have effective procedures in place to protect both patients and health care workers from viruses that are spread through contact with bodily fluids. The viruses we have long been concerned with include HIV and hepatitis C, among others. Recently, Ebola has been added to the list of viruses that IVF lab technicians should be aware of. Currently, the odds of being hit by lightning are a thousand (million?) times greater than contracting Ebola in the United States, but it does no harm to be informed and may cause great harm to be ignorant.

The CDC and the World Health Organization (WHO) have published the following information on their respective websites:

CDC information on Ebola in semen
WHO information on Ebola in semen ( and (

Perhaps the most troubling piece of information is not that Ebola has been found in semen – that is to be expected since semen is a bodily fluid, but that it has been detected in semen as much as 91 days after the infection has been diagnosed. This surprising observation suggests that perhaps the virus may embed with a round of sperm cells that are in production at the time of the infection– and until they are flushed from the system when mature- the virus persists in this niche. The CDC recommends: Once someone recovers from Ebola, they can no longer spread the virus. However, Ebola virus has been found in semen for up to 3 months. People who recover from Ebola are advised to abstain from sex or use condoms for 3 months.

This underlines the fact that in a lab setting, technicians must develop consistent adherence to universal precautions for their own safety and the safety of their patients to avoid infection with both old and new viruses. Universal precautions includes the consistent use of personal protective equipment (such as gloves) and frequent hand washing.

Everyone should know that there is some risk of exposure to the virus through sex for up to 3 months after an Ebola patient recovers from the life threatening acute infection.



Q from U: How many embryos should I transfer?

September 26, 2014Carole 4 Comments »

The question of how many embryos to transfer in a fresh IVF transfer comes up fairly often in one form or another. The question below is derived from one recently asked.
Q:. I’m starting my first IVF cycle, just before I turn 41. At age 37/38, I had done two cycles to freeze eggs, and so have about 30 eggs on ice. I am scheduled to do a fresh cycle because that a fresh cycle is covered by my insurance and a frozen embryo transfer cycle is not. The clinic is pushing me to agree to a single embryo transfer, even before I know if I get any eggs, let alone embryos.  I know that in most cases, a singleton pregnancy is safer than a multiple pregnancy but on the other hand I know my age makes it very unlikely any given embryo will implant. Do you have any information that would be helpful to be in making this decision?

A: Yes!!, there is a resource to help doctors (and patients) make these decisions. The American Society for Reproductive Medicine (ASRM) publishes guidelines for how many embryos to transfer. This document is free for download to anyone from this link:  I have recreated the table from the article below.

Stage-Prognosis Under 35 35-37 38-40 41-42
Cleavage -Favorable 1-2 2 3 5
Cleavage-Other 2 3 4 5
Blastocysts- Favorable 1 2 2 3
Blastocysts – Other 2 2 3 3

These professional guidelines are written by a committee of physicians and represent a consensus view of what is a reasonable number of embryos to transfer for most patients depending on three factors- maternal age, stage of the embryo (day 3 cleavage or day 5 blastocyst) and whether the prognosis for pregnancy is favorable or “other”.

The patient’s maternal age is the largest contributing factor to infertility, followed by every other infertility factor. If a patient has no or few other factors that could decrease their chances of getting pregnant, they have a ‘favorable” expectation of pregnancy from the transfer. Alternatively, if they have other variables that make it less likely that they will achieve pregnancy, then they have an unfavorable prognosis or as termed in the guidelines– “other” than favorable prognosis.

The transfer number recommendation is an attempt to balance the need to increase the patient’s chance of getting pregnant at all (transfer more embryos) while decreasing the chance of a multiple pregnancy occurring  which could end badly for the patient (transfer fewer embryos).

As we age, our chance of pregnancy plummets because more of our eggs, (and therefore our embryos), will have an abnormal number of chromosomes which makes the embryo unable to progress in pregnancy even if it initially implants. To compensate for this, it is suggested that more embryos be transferred per attempt in older patients.

The older patient who asked the question about how many to transfer was being encouraged to transfer only a single embryo – which falls outside of these recommendations. It is possible that her doctor has made a judgement that ANY chance of multiples is too hazardous for this particular patient- perhaps because of some  known uterine issues specific to this patient.

More and more embryo transfers are made with blastocyst stage embryos. Why transfer fewer blastocyst embryos than cleavage stage embryos? The reason is that embryos that reach blastocyst stage have proven that they are healthier than another embryo that stalls out on day 3 or 4 and never makes it to blastocyst stage. If you are transferring on day 3, you have less information about the embryos and so have to assume some will stall out, so more are typically transferred on day 3. Of course, if your embryos are all good on day 3, you have just really increased your chances of a multiple pregnancy- !- which is a problem and  is why day 3 transfers are falling out of fashion.

Patients should understand that they have a right to ask the doctor to explain why they are recommending one course of clinical action over another. Most doctors don’t mind doing this at all. If you encounter a lot of resistance to questions or the answers don’t make a lot of sense, it might be time to find another doctor who is more accepting of their role as educator and health care partner.

Any professional recommendation may change for a particular patient based on additional or new  information that may be available. For instance,  pre-implantation genetic testing (PGD)  to identify embryos that are genetically abnormal from those that are normal can result in a recommendation that only one embryo be transferred. If only normal embryos are transferred, it is  more likely that the normal embryo will implant –and stay!!- than an abnormal one.  The table above assumes that we have no genetic information- and some of the embryos available will be normal and more likely to result in a good pregnancy and others will be abnormal and have little or  no chance of creating a viable pregnancy. So if a doctor has a known group of normal embryos to choose from, typically, they are inclined transfer fewer or just one in a single transfer attempt.

When cryopreservation of embryos was less successful than it is today, the thawed embryos would be partially damaged and not look so good at thaw. Because they were considered lower quality in terms of their odds of implanting, more thawed embryos would be transferred to a patient in a thaw cycle than a fresh cycle. Today, vitrified embryos look as good as fresh, so there is no need to transfer more previously-vitrified embryos.

In a case where the embryos are derived from donor eggs, the recommendation to transfer disregards the age of the recipient (intended mother) all together. Most donors are well below 35 years of age, so the recommended number to transfer will be based on this age group, not the age of the intended mother.

Medicine is still more an art than a science, and although we are always on the lookout for more tests to give us more information to make better decisions and recommendations, there is still lots of gray area where the physician leans on his/her experience in addition to the data.  I think it is useful for patients to understand the professional guidelines that exist, especially when their doctor recommends a course of action outside of the professional guidelines. Hopefully, this will lead to better conversations between doctors and patients.

Q from U: When should you consider donor eggs?

August 13, 2014Carole 4 Comments »

I received this question from a reader today:

When a woman (very close to 40 ) has her first IVF cycle and responds great to medication, they retrieve 13 eggs – and only 1 fertilizes (with great sperm) and some of the eggs appear to have abnormalities, does she chalk it up to bad eggs or bad luck with that cycle? Even If she conceived naturally 3 years ago, with 2 miscarriages in between. How common is this in the ivf world and is it realistic that changes to protocol DHEA etc. make a difference, Or does this often signal a time that doctors recommend Donor Eggs.

This patient’s situation is not unusual. Having an average number of eggs retrieved and having successful fertilization, while an encouraging and necessary step in treatment does not  guarantee that the embryos produced have a normal number of chromosomes- especially in a patient approaching or past 40. The past history of recurrent miscarriages can be explained if the embryos in those pregnancies had an abnormal number of chromosomes.

As we age, we produce more eggs that didn’t segregate their chromosomes properly in the last stages of egg production and the resulting mature egg has more or less chromosomes than what is normal. You can read more about the link between chromosomal number abnormalities  (aneuploidy) and miscarriage here.

DHEA which is a male hormone or androgen, has been  used with IVF stimulation  in an attempt to improve parameters of the IVF success (eggs retrieved, eggs fertilized, embryos available for transfer, and pregnancy rate).  Some studies support the use of DHEA but it is still controversial, with many opposed to its routine use for all patients, due to its effect on increasing androgen levels. DHEA is used in menopausal women to relieve some menopausal symptoms– bone loss and sexual function issues. DHEA is also used for lupus patients to reduce the effective dose of steroids they need to take. DHEA may be helpful for certain patients but side effects are not understood and DHEA should only be used under doctor’s supervision.

Doctors vary in when they decide it is time to suggest donor eggs. If they believe in DHEA, they may offer that first. If they have good results with aneuploidy testing of embryos, they might suggest another round of IVF in which every embryo is tested for chromosomal number and abnormals are not transferred. This approach also has its detractors because to have anything left after testing, you need a goodly number of eggs (and embryos) to start with–a situation which is precisely lacking in the older patient. Donor eggs is usually suggested sooner rather than later at most clinics because this is the fastest, most reliable method, to get older patients pregnant and on their way as a pregnancy success.

Hopefully the doctor who suggests donor egg as a treatment also takes same time to explain why donor eggs are not just a technical fix and require a little more consideration than most other interventions. If you use donor eggs, you will be able to experience pregnancy first hand (in most cases) but your child will not be genetically related to you. We live in a society composed of individuals with wide religious and cultural attitudes toward the use of donor eggs (or sperm or embryos) . But almost every culture has a great reverence for genetic relatedness and genetic family – whether it is overt or subtle. We relish finding evidence of that genetic link- “You have your father’s eyes, etc”.

You need to ask yourself:

  • Will I ever regret that this child is genetically unrelated to me?
  • Will the people that are closest to me accept this child?
  • Will I have to keep the origin of the child a secret from my closest friends and family or from the child?
  • What will I do if my child wants to know who the egg donor is at some future date? Does the clinic offer a means to connect with this donor in the future? (Often, donor eggs are 100% anonymous and the child has no way to access their egg donor information- ever. Records are not required to be kept past 10 years – at the longest- so the records are often long gone when the child is 18. That is why some groups have formed to find donor siblings if they know the donor code and the ART clinic but this is a hit or miss method to find donors).

These social and emotional issues are difficult for many patients. Egg donor is an easy technical fix- you are much more likely to get pregnant if you use a donor’s eggs- but make sure that you are comfortable with the  long term implications for you and your family.  Most good programs can refer patients to therapists who specialize in this third party reproduction issues so that patients have a chance to think about and speak with their partner about as many implications of the procedure as they can before they agree to use donor eggs.

You need IVF but can’t afford it. What next?

July 16, 2014Carole No Comments »

So you just received the devastating news that you and your beloved won’t be having children the old fashioned way because one or both of you have some reproductive medical issues that are getting in your way. IVF could help you but you can’t afford the $20,000 average price of an IVF cycle. You looked into adoption but that can cost twice as much, especially if you are adopting a child overseas or you may already be too old to adopt because of some adoption rules. So what can you do?

You might want to look at some strategies for finding insurance that covers IVF treatment or determine whether your employer’s insurance plan may already actually provide some of the benefits you need. Or if you can make a compelling business sense to do so (and you can), you might be surprised to find your employer may well add IVF benefits to the company plan.

Fertility within Reach is a non-profit organization that can be your guide in understanding the facts behind insurance coverage for infertility to:

1) determine what your existing insurance plan will cover.

2) talk to your fertility  doctor about your options.

3) explain to your HR department why adding IVF insurance may well benefit the company with minimal cost.

4) talk to your legislator about why the current state laws need to be changed to add infertility coverage to basic insurance plans.

Money Magazine recently interviewed Davina Fankhauser, Co-founder of Fertility Within Reach about how FWR can help people suffering from infertility negotiate the insurance maze.  Davina is an amazing advocate for infertility patients. I met her in person at last year’s ASRM meeting in Boston -although we’d spoken by phone and emailed for more than a year before. I was and continue to be impressed by her passion to help others help themselves. She’s a small person, but an energetic dynamo when it comes to making a difference for fertility patients.

She will tell you that you are not alone and you do have options to explore.  You can read the Money Magazine article  online or buy the print copy at new stands now. You can also see a list of other resources for conception help here.

Don’t assume that you can’t afford IVF. You may have options you don’t know you have. Check out Fertility Within Reach’s website  and see what you can do for yourself. You might even surprise yourself by just how powerful you can be!




ASRM objects to Supreme Court Decision on contraceptive coverage

June 30, 2014Carole No Comments »

I was pleased to see that the American Society for Reproductive Medicine (ASRM) released a press release objecting to the Supreme Court’s decision today to allow a for-profit corporation to decide to not provide certain types of contraceptives due to religious beliefs held by the owners. See the press release copied below:

ASRM BULLETIN  Volume 16, Number 29

June 30, 2014

 ASRM Strongly Objects to Today’s Supreme Court Decision  

 ASRM has issued the following press statement today in response to the U.S. Supreme Court decision in the Burwell v. Hobby Lobby and Conestoga Wood v. Burwell cases.  In a 5 to 4 decision, the court ruled that closely-held firms like Hobby Lobby are protected by the Religious Freedom Restoration Act of 1993. The law dictates that an individual’s religious expression shouldn’t be “substantially burdened” by a law unless there is a “compelling government interest.”

American Society for Reproductive Medicine Comments on Hobby Lobby Decision

Statement Attributable to Rebecca Sokol, MD, President

Monday, June 30, 2014

For more information, contact Sean Tipton on 202-421-5112 (mobile),

“We profoundly disagree with the Supreme Court’s decision today. Simply put, the moral views of a patient’s boss should have no bearing on his or her ability to access needed medical treatments. Allowing an employer to impose their beliefs about reproduction on their staffis simply wrong, particularly when those beliefs are so clearly misinformed on the scientific and medical facts.

The medical facts are clear: contraception saves lives, the use of contraception leads to healthier babies, healthier mothers and lower costs.  In no other field of medicine do we allow employers to substitute their judgment for that of patients and physician, it should not be allowed just because the subject matter is reproduction.”

Here is another instance when –because the topic is reproduction, and female reproduction at that –we make it more difficult for the individual to exercise basic reproductive rights over her own body. This ruling basically defers to the employer as to whether they want to offer contraception in their benefit plan. Yes, employees can still pay out-of-pocket if they can afford to- but  if employees aren’t wealthy or self-insured, this ruling makes it more difficult for those employes to dain access to this basic part of health care.

You might be asking- why should I care about contraceptive rights?  I am trying to get pregnant, not trying to prevent it. The reason everyone should care is because the same interests that want to intervene,  limit access or erect hurdles to easy and inexpensive access to contraception are the same interests who don’t think much of IVF, and want to limit its use or at least make sure that they don’t have to pay for it. It’s all part of the same fight for reproductive freedom and access to reproductive health care.

Maybe it’s time to reconsider having universal health care through the government and stop offering healthcare through employers. Employees should not have to consider and accommodate their employer’s every religious belief just to get fundamental healthcare. And what is more fundamental than the autonomy to decide when and how you will start and expand your family?

Q from U: Philosophical questions about IVF

June 15, 2014Carole 1 Comment »

The other day I received an email from a patient who wanted to understand what it feels like emotionally to be an embryologist. I thought her questions were interesting and ones that most people in this field probably think about at one time or another – or obsess about always. First, I preface my answers by saying, that I am one of thousands of embryologists and there are probably almost as many answers to these types of questions as there are people who think about them and I don’t pretend to speak for every embryologist. As usual, I can only share my own thoughts, opinions and experiences. The questions are in bolded italics below.

Q. I find this process mind-boggling and amazing. I totally get that a process which is magical, stressful, and suspenseful for patients is routine for embryologists. But I’m curious if you/your team maintains a reverence for the work, or if you strive to remove yourselves from the human aspect.Like, do you note the names on the dishes and ever wonder about the hopeful intended parents, especially when you see the same names repeatedly, making multiple attempts?
A: For me, I tried to stay focused on the technical details when I was working. Considering the emotional context- the implications- of the routine work too much is a dangerous distraction and more likely to make you miss a step, drop something or forget to do something which is going to harm the very people you are emotionally worried about. When I saw the same names again and again, I usually had some back story from the nurses which made the patients even more real than just a name on a plate- and it was more likely that I might actually have met the patient before so yes, of course, it becomes less a puzzle to solve as a obligation to deliver results.
Q.When selecting embryos for transfer, do you ever have feelings of “playing God” and wondering whether the selected potential life will be a “better” human being someday than the one that isn’t selected?
A: For me, it was about, which of these embryos has the best chance to make it, period. You always choose for implantation potential based on any data you have about the embryos (appearance, progression in culture, genetic results, gender preference of parents etc). If the embryo doesn’t implant, the rest of your musings are pointless. Never felt like I was “playing God”- not that naive. :) There are plenty of steps after my role that have to go right to make a healthy live birth. Embryologists just get the process going, facilitate or help nature;  they don’t determine the end result.
Q. When you discard the embryos that don’t make it, does it feel like a different kind of loss than if you were working with cell culture in some other format?
A. Yes, there is always a twinge of “what if”. Some embryologists, feel compelled to leave the human IVF field because they are so troubled about having to follow patients’ directions to discard embryos, or more troubling, clinic policy to discard when the patient abandons the embryo(s) and does not provide a directive for disposition. This emotional distress about discarding embryos that many embryologists feel to some extent may be due to religious reasons or simply the feeling of disappointment that not all embryos that might have the potential to implant are given the chance. Some embryologists deal with this emotional dilemma by enthusiastically supporting  and encouraging embryo donation from one patient to another. For me, I never felt that what I wanted for other people was relevant. I didn’t feel it was my right to tell others how to have or not have children. Every child should be wanted, but that doesn’t mean that every embryo must be given the chance to implant. In my opinion, that is up to the intended parents, not the medical staff that facilitate family building.
Q. When we got transfer results, we were told that our embryos are in Tray #7. Does the team keep all embryos from a single patient together, or is there an effort to distribute them somehow so the risk of tray damage (like from a tray being dropped) is distributed?
A. This is a policy matter that varies between clinics. I have worked in clinics were we had many multiple dishes for a case. In other clinics, we had one or two dishes that held all the patient’s embryos. There are arguments pro and con for each approach. If you distribute the embryos for a case into multiple dishes (or trays) , you have some insurance against total disaster in case one dish (or tray) holding everything gets dropped. However, multiple dishes mean more manipulations for each case, which arguably drives up the chance of a technical mistake. With more dishes in a single case, you will have to open the incubator door more times and may have the dishes out longer to perform the manipulations on the embryos across multiple dishes, which also increases the time outside the ideal environment that is the incubator. Over time, I have come to the conclusion, that less is more and so minimize the dishes needed for each case.
Q. Does your work affect how you feel about parenting? Does knowing how hard it can be to conceive life make you more appreciative of it, and less tolerant of child abuse or neglect?
A. I already had one child and was pregnant with my second when I started working in IVF so I already had very real experiences with parenting so I don’t think caring for embryos made that any more meaningful at that point. I did sometimes feel guilty about being pregnant in front of patients, especially since I’d never experienced infertility in my own life. I knew I was lucky in that respect and never took my fertility for granted. I don’t equate embryos with living breathing children. Not all embryos will implant and result in a child, even if given every opportunity to do so. I think my intolerance for child abuse or neglect rises out of my humanity, not my embryology experience.

Things to know BEFORE you start IVF

June 8, 2014Carole 1 Comment »

My local paper carried this article, ” 10 Things Fertility Clinics Won’t Tell You“, by ELizabeth O’Brien. which provides in one article, much important information which patients considering IVF should understand before they start treatments. Read her article and then if you want more information – with many more links to even more information- check out these previous Fertility Lab Insider posts for each of the 10 topics. You might want to bookmark this page and come back for IVF info in smaller doses. :) Good Luck!!!

1. We can’t change basic biology

Female Infertility Diagnosis: Ovarian Reserve

The embryo beauty pageant and why your eggs don’t care if you yoga

What is aneuploidy?

Egg vacuoles in IVF

Female Infertility Diagnosis: plumbing Problems

Epididymis: Where sperm get fine-tuned and functional

Sperm Morphology: Kruger’s Strict vs. WHO criteria: what’s the difference?

Izumo, Meet Juno: Fertilization Receptors revealed

2. You might be using the wrong drug or wrong doctor

Finding a good fertility doctor…part one

Advocating for yourself: Finding a good IVF clinic

Interview your doctor

Common practices of the best IVF clinics

Finding your “best fit” IVF program

3. We’ll break the bank

Affordable IVF?

Insurance coverage for IVF

Financial planning for Infertility Treatments

Stretching the Infertility Dollar

How to get insurance coverage to pay for IVF : and a new forum to get help

Widespread access to effective infertility treatments remains elusive: what you can do to change that

New study on IVF insurance in the US

Is your fertility doctor a predatory lender?

Infertility and the Affordable Care Act: Part One

The politics of Affordable IVF

Will the Affordable Care Act make Fertility Care Affordable?

4. Our money-back guarantee isn’t such a great deal

Paying for IVF: Shared Risk Programs

5. We don’t have a good handle on every health risk

Gambling with twins, triplets and more

ASRM 2013 Update: Safety: Effect of the ART Lab Environment

ASRM 2013 Update:Safety: Singleton Pregnancy

ASRM 2013 Update: ART Safety: The Twin Effect

IVM Concerns: Large Offspring Syndrome

6. Where you live may determine how this goes

Using CDC reports to find a good fertility doctor…part two.

7. Seek out support.

Infertility Support Groups

8. Good Luck understanding our success rates

How do you know your IVF clinic is good?

Also see many of the posts under the topic 2  and 6 above which also address the issue of how and why to use the free public US success rates databases (on the CDC and SART websites) to find better than average clinics.

9. Maybe it’s time to stop treatment

When is it time to stop IVF?

Are you addicted to IVF?

Is IVF working for you? what are the signs of a good IVF cycle?

10. Preserving your fertility, don’t bank on it.

Egg freezing: you’ve come a long way baby

 Finding a good egg freezing clinic

Egg freezing lost “experimental” label but still not routine for all labs


What I couldn’t say when I was working full time in IVF

June 1, 2014Carole 4 Comments »

Before I started my own medical writing consulting business,  I was an IVF lab director. When I was working for someone else, there was a lot I couldn’t say to patients because that was not my role. I still don’t give medical advice, but I often couldn’t give lab-related advice that might be considered critical of the field or of my employer. Here are a few critical facts I can tell you now:

Some IVF programs are not very good. If you are a “virgin” IVF patient- here’s what you shouldn’t do: head off to the nearest IVF clinic based on a radio or cable TV Advertisement or even your best friend or  Ob Gyn’s recommendation. What you should do is do some cold analytical research to find the best program you can get to,  because not all IVF programs are better than average and that range of pregnancy rates  starts at a dismal 13% pregnancy rate and goes to a 66% pregnancy rate. Now, if you want to donate your eggs to “research” , you can go to the 13% pregnancy rate clinic. You won’t pay any less but boy, you will have many chances to “practice “doing IVF until your 13% clinic gets it right. Or you can go to and look up the clinics in your area. You can also look at a chart of the national average of all reporting clinics here:  The good news is that the average pregnancy rate has been steadily improving and in 2011, in the US, the average pregnancy rate for the youngest age group using their own eggs was 43%.

The fact that IVF patients can access the outcome statistics of every IVF program in the country is an amazing thing. If you have any other medical complaint, you do not have this sort of resource. Like any data set, it has its limitations which are outlined here  Even with some limitations, these data are an amazing resource and if you want to increase your chances of getting pregnant sooner rather than later, you really should do a little research before you hand over that $12,000 (or more) for a SINGLE IVF cycle.

Some IVF clinics in the US are run more like a car showrooms with special deals, upgrades and options, than like a medical calling. Unlike other medical services which are  universally covered by insurance (eg. cancer treatments, other ailments), IVF is still considered to be more like cosmetic services than cancer care. IVF is perceived to be “optional” and IVF programs will vigorously compete to get your money and your business. You might be offered upgrades and special packages to enhance your experience, massages, acupuncture etc.  I have become rather cynical about the fancy medical offices and expensive advertising campaigns, precisely because I have experienced lovely high-end waiting rooms in the front end and dirty incubators in the back end. I have struggled to try to convince thick-headed, greedy lab owners that yes, they did need a lab manual with updated written protocols and procedures and methodical training of lab staff to ensure high and reproducible pregnancy rates. That yes, we might have to risk the “brand” and clinic “image” in order to be honest and ethical with patients about poor outcomes (eg. the tech lost the embryo during manipulations at thawing instead of “the embryo did not survive the thaw”).  Yes, the embryo is just as dead in both instances but the second instance- while preserving clinic image-  is far more damaging to the patient because it implies there is something intrinsically wrong with the embryo and the patient. This sort of “managing the brand”patient communication sets the clinic up to look like a hero the next time when the embryo doesn’t get dropped because now the patient believes they are a “hard” patient  and the clinic overcame these patient-based obstacles to deliver a pregnancy– so I suppose from a marketing viewpoint, it’s win-win.

Just remember when you choose a clinic that the front end is all bull-shit. The back end is where your fate will be determined. This makes the public statistics so important because you literally have no other outcome-based data  to compare clinics and unless you are also an embryologist working at the clinic, no way to inspect and evaluate the back end.

So, before you dive head first into an IVF program with both your heart and your wallet,  take some time to do some research and find the best clinic based on outcomes delivered, not promises made. Good Luck!