IVF patients may also benefit from embryonic stem cell research

September 23, 2010Carole 1 Comment »

Usually when embryonic stem cells and infertility are discussed, it’s about how embryonic stem cells, derived from donated IVF embryos can be used to treat various non-reproductive diseases. Recently, in a “proof of concept” breakthrough, researchers announced the results of a rat study in which stem cells restored ovarian function. Premature ovarian failure was chemically induced in a group of rats. Rats which received rat-embryo derived mesenchymal stem cells had restored ovarian function. Placebo treated rats remained in ovarian failure.. Mesenchymal stem cells are derived from the embryonic connective tissue which forms the substrate for cells in the ovary that secrete hormones. Rats in ovarian failure who received injections of these stem cells restored both their ability to produce eggs and  ovarian hormones.

The next step is to see if these rats can reproduce normally and produce healthy offspring. The researchers used male mesenchymal cells so they could identify them in in the treated ovarian tissue by the presence of Y chromosomes- not usually present in the female ovary- in the restored ovarian cells.  One unanswered question, among many, is whether the eggs produced contain the donor’s genetics or the recipient’s.genetics It’s early days yet and decades of research before any clinical application could be considered but it does raise the possibility  that the scourge of female infertility, premature ovarian failure, might some day be curable.

This announcement comes as the federal  funding of stem cell research in the US is  yet again hotly debated. In 1995, the Dickey-Wicker amendment placed a rider on every NIH funding bill which prohibited funding of any research with public money which involved the destruction of a human embryo. It did not make embryonic research illegal per se, but it prohibited all federal funding, the major source of funding for all medical research in the US. California and New Jersey responded by creating state funded centers for embryonic research, bypassing the federal funding ban.

In 1999, a legal ruling exempted research with stem cell lines from this prohibition because the cells in the cell lines were not the original embryos referred to in the Dickey-Wicker rider.  In 2001, President George Bush restricted  funding to 21 cell lines already in existence on the date of his decree. And so there was some limited federal funding using existing lines, many of which subsequently have been found to have limited or no research value, being the earliest attempts at creating useful lines.

A federal judge on August 24, 2010 attempted to eliminate any use of stem cell lines by ruling that the Wicker-Dickey prohibition of federal funding should also apply to research using all cell lines derived from embryonic stem cells.. This was in response to a lawsuit brought by two scientists working on adult stem cell research. These motives of the scientists bringing suit were questioned when it came to light that their own research funding dollars for adult stem cells would certainly decrease if they had to share the finding pie with embryonic stem cell researchers. This further restriction on embryonic stem cell research came after numerous labs, including eight labs at NIH,  had already ramped up work with the existing cell lines and 75 newly approved cell lines,  exempt from the previous restrictions. NIH sent out an announcement to cease research immediately. This confusing legal reversals and re-reversals has  left NIH funded labs in turmoil, and seriously impacts the progress of the existing research.  ASRM recently released a bulletin announcing it’s activism to restore the existing  funding for embryonic stem cell research, prior to the August ruling. You can read ASRM’s open letter to the US House of Representatives, urging action to modify or overturn Dickey-Wicker. Surely, some middle ground can be found which addresses the fears about cloning and ‘slippery slopes” and yet allows research to proceed on excess IVF embryos freely donated by IVF patients who did not choose to “thaw without use”, but wanted some benefit to come from these embryos, but did feel comfortable with donating embryos to others and creating siblings raised in other families. These decisions are tough for IVF patients and should be honored and respected – and funded!

Whenever I think about stem cell research, there are a handful of facts that I can’t ignore.

  • IVF programs work very hard to produce embryos for patients who desperately want to be parents. Embryos are not created lightly by anyone involved in the process.
  • Currently, ART procedures are not well-calibrated to produce only as many embryos as a couple needs to create the family they want. Excess embryos are frequently produced.
  • Donation of embryos to other couples, while noble in concept, is not actually widely accepted by most IVF patients and  has resulted in very few live births.

Embryo donation has not lived up to it’s promise of doing away with the excess embryo problem for several reasons. First, the 400,000 embryos in storage are not “up for adoption” as some activists have claimed, but they are reserved for the use of the patients who produced them. Second, in my experience, most patients do not choose to donate their excess embryos to other couples, unless they have strong religous convictions that make them equate embryos with children. Embryos do not equate with children if you look at it scientifically  because as we all know, only a subset of all created embryos (whether in nature or in the lab) actually result in a live born. There is a lot of embryo wastage in nature too.

Embryo donation is actually an easy option for patients to elect if they feel so inclined because many (most?) IVF  programs have built-in mechanisms for embryo donation within and among the patients within their program.  Why? Because REs are approached by grateful IVF patients who want to donate their excess embryos to other patients in need and are also approached by needy patients who want to do a frozen embryo transfer (less expense than IVF, less risk) with a donated embryo. Embryo donation is performed within many IVF practices….. quietly, ethically, cheaply and without any federal funding.

Which is why the million dollars of federal funds donated to promote  embryo donation was a publicity stunt and not particularly effective. The million dollars of tax payer money donated by the Bush Administration to the National Embryo Adoption center/Nightlife Christian Adoption/Snowflakes has resulted in a ridiculously low number of live births from embryo donation nationwide- somewhere between 16 and 200 birth nationally since it’s inception. I would guess that most moderately sized programs are responsible for at least a dozen births every year from unsubsidized in-house embryo adoption. Arthur Caplan, the ethicist, hardly a friend of IVF, also called the federal funding of Snowflakes Adoptions a bad idea. He points out that because excess embryos are produced by patients with infertility problems, they are more likely not to implant. There is some truth to that, but he forgets that most of the time embryos are donated by patients who have reached their desired family size using the sibling embryos to those they plan to donate. Patients that presumably have unhealthy embryos and don’t get pregnant typically use up all the embryos in storage on their own transfers so have no excess embryos  to donate.

If our government is funding/has funded embryo adoption, why shouldn’t stem cell research (the Other option besides discard without use) also be funded? Either option gives the poor unwanted embryo a higher purpose to its existence than being destined for the biohazard bag and incineration. No one benefits from the discard without use option and that is where the majority of  excess embryos end up, either directly discarded or abandoned, to be reluctantly discarded by the clinic when the space/resources for storage at the clinic are exhausted.

It’s a thorny problem without an easy fix. Some countries like Germany and Italy forbid embryo freezing and promote egg freezing, effectively limiting embryo production to the number that can be safely transferred in the fresh cycle (not more than 3). No excess embryos are produced. Excess eggs can then be fertilized in a later thaw cycle or discarded with few ethical qualms if they are not needed. With the improvements in egg freezing, we may be coming to the time when fewer embryos can be produced int he fresh cycle WITHOUT reducing pregnancy rates. Until then, we appear doomedto fight and re-fight the same tired battles over what to do with excess IVF embryos.

© 2010, Carole. All rights reserved.

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