Clinical Trials at CHR
Thin Endometrium Trials
Thin Endometrium Study: Summary
CHR, a leading fertility center in New York City, conducted 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. Patients who have had multiple implantation failures in IVF cycles, or have had endometrium that is too thin for embryo transfer were considered candidates.
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- See the thin endometrium trial on ClinicalTrials.gov
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Improvement of Thin Endometrium Study
CHR conducted two clinical trials of a medication called Neupogen (G-CSF). Our hypothesis was 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, 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 were designed to test this hypothesis.
How Can I Participate in Thin Endometrium Clinical Trials?
Participation in the G-CSF trials is no longer availalbe, as the trials have been closed.
Half of the women in the trial received G-CSF as an infusion and the other half received only salt water (i.e., placebo). Neither the patient nor the physician knew to which group patients were randomly assigned. As this was a cross-over study, anyone who received placebo and did not get pregnant were offered G-CSF in the next cycle.
What were the results of the Thin Endometrium Clinical Trials?
The clinical trial failed to demonstrate benefits of intrauterine perfusion with G-CSF. In normal IVF patients, G-CSF did not affect endometrial thickness, implantation rates, or clinical pregnancy rates. However, because these results were obtained in an older patient population, they may not necessarily apply to younger women.
So far, the CHR group has published three articles regarding our experience with G-CSF, including the first case report, a cohort study and a randomized trial:
- Gleicher N, Vidali A, Barad DH. Successful treatment of unresponsive thin endometrium. Fertil Steril 2011;95(6):2123.
- Gleicher N, Kim A, Michaeli T, Lee HJ, Shohat-Tal A, Lazzaroni E, Barad DH. A pilot cohort study of granulocyte colony-stimulating factor in the treatment of unresponsive thin endometrium resistant to standard therapies. Hum Reprod 2013;28(1):172-177.
- Barad DH, Yu Y, Kushnir VA, Shohat-Tal A, Lazzaroni E, Lee HJ, Gleicher N. A randomized clinical trial of endometrial perfusion with granulocyte colony-stimulating factor in in vitro fertilization cycles: impact on endometrial thickness and clinical pregnancy rates. Fertil Steril 2014;101(3):710-715.
Want to know more?
To learn more about CSF trials at CHR, simply complete the Thin Endometrium Clinical Trials Form.
Last updated: Apirl 29, 2014