Treatment Options

Clinical Trials at CHR: Thin Endometrium

thin endometrium, implantation failure

Thin Endometrium Study: Summary

CHR, a leading fertility center in New York City, is conducting two clinical trials to determine whether a compound called G-CSF can improve the endometrium (lining of the uterus). Because embryos need a properly thick endometrium to implant and grow, improvement in the endometrium may improve the embryo implantation and pregnancy rates. If you have had multiple implantation failures in IVF cycles, or have had endometrium that is too thin for embryo transfer, you may be a good candidate.

Participation in this trial is free, but the costs for the routine part of your IVF cycle will be your responsibility. If you are already considering pursuing an IVF treatment at CHR, please consider participating in thin endometrium study. Participation may enhance your cumulative pregnancy chance, although, of course, it is not proven yet.

Improvement of Thin Endometrium Study

CHR is currently conducting two clinical trials of a medication called Neupogen (G-CSF). Our hypothesis is that using Neopogen (G-CSF) at strategic points during an IVF cycle can enhance the endometrium (uterine lining), improving the potential for embryos to implant.

What Is G-CSF?

Neupogen is already approved by the FDA for treatment of men and women whose production of white blood cells is reduced by chemotherapy. This means that clinical trials of Neupogen were already conducted among people receiving chemotherapy, and benefits of increasing the white blood cell counts were thought to outweigh associated risks.

How Might G-CSF Improve Endometrium and Embryo Implantation?

Considerable evidence already exists from laboratory studies that the CSF family of compounds provides an important part of signaling between embryo and uterus. Animals that cannot produce CSF have poor embryo implantation. CSF is produced by mammalian embryos, and there is evidence that linings of uterus are able to produce and recognize CSF compounds.

We and others have, therefore, reasoned that CSF might enhance embryo implantation. There are a few existing human trials in which G-CSF was given as injection or intravenously to women, who then experienced increased pregnancy rates. However, study sizes and the observed increases in pregnancy rates were small. Therefore, at the moment, their conclusions have to be considered "inconclusive."

We reasoned that placing the G-CSF directly into the uterus might improve development of the lining of the uterus and further increase the chance of pregnancy. We tried this approach with experimental consents on a few patients over the summer of 2010, and had very promising results. We, therefore, decided to launch two clinical trials after receiving formal approval from our Institutional Review Board (IRB). The trials we are now conducting are designed to test this hypothesis.

How Can I Participate in Thin Endometrium Clinical Trials?

Participation is offered to all of our patients. You will be asked whether you wish to participate shortly before oocyte retrieval. If you are being prepared for frozen embryo transfer or a donor egg cycle, we will offer participation in the clinical trial a few days before your embryo transfer.

If you choose to participate in the trial, we will ask you to sign an informed consent, describing the trial and possible risks and benefits of participation. You will also be asked to fill out a few study forms, describing yourself, your habits and your reproductive history.

Half of the women in the trial will receive G-CSF as an infusion and the other half will receive only salt water (i.e., placebo). Neither you nor your physician will know to which group you were randomly assigned. As this is a cross-over study, anyone who receives placebo and does not get pregnant will be offered G-CSF in the next cycle.

If you choose not to participate in the clinical trial, we will continue to treat you in routine manner but we will not be able to offer you G-CSF infusion, since this treatment is not yet considered "proven".

No Additional Cost to Participate in Thin Endometrium Clinical Trials

There will be no additional costs to you as a participant in one of the G-CSF trials. However, you will still be responsible for the routine part of your IVF cycle costs.

We will analyze the results on an interim basis. If we find proof that the G-CSF is helpful, we will end the trial, and begin to offer treatments with G-CSF on routine basis.

Want to know more?

To learn more about CSF trials at CHR, simply complete the Thin Endometrium Clinical Trials Form.