This phase 3 trial will investigate the effectiveness of a new drug FE 999049 for the treatment of infertility.
The main outcome to be measured will be the ongoing pregnancy rate.
There are several steps in the treatment of infertility. The first step involves harvesting eggs or oocytes. Once oocytes are harvested, in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) is performed. If this is successful, a fertilized embryo is formed and suitable for implantation in the uterus (womb). In order to harvest oocytes, the ovaries may require stimulation (controlled ovarian stimulation). This is achieved using drugs. In some cases, these medications are not effective or cause a serious side effect called ovarian hyperstimulation.
FE 999049 an experimental drug for COS. It is similar to the natural hormone, follicle-stimulating hormone (FSH). FE 999049 is a recombinant (synthetic) form of FSH.
This phase 3 trial will investigate the effectiveness of FE 999049 for COS. The main outcome to be measured is the ongoing pregnancy rate.
Who are they looking for?
550 female patients will be recruited for this trial. Women with tubal infertility, endometriosis or unexplained infertility can take part in the trial. To participate in this trial, women should have a regular menstrual cycle (24-35 days), normal uterine function (no clinically interfering fibroids) and negative Hepatitis B, C and HIV results.
Patients cannot take part in the trial if they have previously undergone more than one COS for IVF/ICSI. Participants must not have severe (stage 3-4) endometriosis, an absence of ovulation, recurrent miscarriages, history of thromboembolism (blood clots), hormonal disorders, endocrine tumors or kidney/liver dysfunction.
How will it work
Participants will be randomly assigned to receive either FE 999049 or placebo (inactive drug). The stimulation protocol will last up to 22 days. If successful, IVF/ICSI will be performed and fertilized embryos will be implanted.
The main outcome will be the ongoing pregnancy rate after implantation.