Houston Fertility Institute (HFI) is proud to announce its participation in a clinical trial for a new investigational in vitro fertilization (IVF) treatment. This trial, the Thrive-IVF Research Study, is for patients who have previously not been successful with IVF. HFI is one of 20 participating sites chosen from around the country.
What is IVF?
In vitro fertilization is a procedure in which oocytes (eggs) are retrieved from the ovaries and then fertilized by sperm in the laboratory. In nearly all cases, women receive medications to allow the ovaries to produce multiple eggs. After fertilization, the resulting embryos are grown in culture for three to five days, and then embryo(s) are transferred into the uterus. Extra embryos are frozen (cryopreserved) for later use. The process of transferring cryopreserved embryo is referred to as an “FET”.
Who is eligible to participate in this study?
The majority of women undergoing IVF between the ages of 21 and 38 years will to achieve a pregnancy and deliver a healthy baby. Unfortunately, some women will not have a successful pregnancy despite several attempts with IVF and FET.
This study is evaluating patients between 21 and 38 years of age who have not had a successful pregnancy with IVF and FET. Women who have had good quality embryos transferred in three cycles and have not had a successful pregnancy are being recruited to participate. Two of the cycles must be in a “fresh” IVF cycle. Patients who have had negative pregnancy tests or early pregnancy losses in these cycles are eligible.
What is the study examining?
This study is examining the ability of a chemical called granulocyte colony stimulating factor (G-CSF) to increase ongoing pregnancy rates in patients who have not been successful in previous IVF cycles. This chemical is normally produced by white blood cells (also called leukocytes) in the body. The G-CSF used in this study is produced in the laboratory and is called “NT100”. NT100 is an investigational drug.
Preliminary studies have shown that G-CSF, when added to culture medium, may improve embryo quality. In addition, initial studies in other similar G-CSF products have suggested that administration of G-CSF may improve pregnancy rates in patients who have failed to have embryo implantation and may also improve ongoing pregnancy rates in patients who have had early pregnancy losses.
What is provided by the study sponsor?
Eligible patients will receive the IVF cycle, including study-related medications at no cost. Patients electing to participate will be randomly allocated to one of two groups. One group will receive the study medication (NT100), while the other group will receive a placebo (inactive) medication.
Is there any difference in treatment approach for those patients participating in the study?
Patients will be required to take additional injections after the embryo transfer. In addition, there will be office visits and some additional bloodwork for patient who elect to participate in the study.
Patients who participate in the study will have embryos transferred on the third day of embryo culture. The usual practice at HFI is to transfer embryos on day five of culture. The reason to transfer on day three is to standardize the day of transfer for all centers across the United States.
How do patients find out more?
If you are interested in learning more about the Thrive-IVF study and whether you may be eligible to participate, please call 281-357-1881 to speak with the clinical research coordinator.
“We are proud and excited to participate in this clinical trial,” said Dr. Witz, IFV doctor and director of clinical research at Houston Fertility Institute. “Clinical trials for IVF offer opportunities for advancing infertility care.”
About the author:
Dr. Craig A. Witz – Director of Clinical Research
Dr. Craig Witz did his undergraduate studies at Harvard University where he graduated with honors. He attended medical school at the Baylor College of Medicine in Houston. He completed both his Ob-Gyn residency and Reproductive Endocrinology and Infertility fellowship at The University of Texas Health Science Center at San Antonio… View Dr. Witz’s full story on becoming one of the best Texas IVF doctors