corifollitropin alfa

The high prevalence of poor ovarian response in women undergoing ovarian stimulation is a main therapeutic challenge that affects pregnancy outcomes in such patients. The current clinical trial aimed to compare the pregnancy outcome of corifollitropin alfa (CFA) versus recombinant follicle-stimulating hormone (rFSH) used in the gonadotropin-realizing hormone (GnRH) antagonist protocol in poor ovarian response patients.

We performed an open-label balanced block randomized clinical trial on 117 Iranian women with poor ovarian responses who were seeking treatment for infertility. Reporting followed the CONSORT 2010 guidelines for parallel group randomized trials. Patients were randomly assigned to the CFA group (a single injection of 150 µg CFA) or the rFSH group (300 IU rFSH on a daily basis). To avoid premature luteinizing hormone (LH) surges, treatment continued with a daily subcutaneous injection of 0.25 ganirelix, starting from day 6 of stimulation up to the hCG administration day. The primary investigated outcomes were the number of obtained oocytes and the number of metaphase II oocytes. Implantation rate, chemical pregnancy, and clinical pregnancy were the secondary outcomes examined, and study participants were followed up to ascertain the interested outcome.

The average number of mature follicles in CFA was 5.0±2.1, which was significantly higher than the rFSH group (4.2±1.7) (P=0.021). The average number of puncture follicles and the number of embryos were significantly higher in the CFA group than in the rFSH group (P<0.05). Chemical pregnancy was observed in 32.2% and 30.5% of patients in the CFA and recombinant-FSH groups, respectively, and the observed difference was not statistically significant (P=0.748). We observed no statistically significant difference despite a relatively higher clinical pregnancy in the CFA group (P=0.398).

A single injection of CFA and a daily injection of rFSH could improve pregnancy outcomes in women with poor ovarian responses who underwent IVF. These two alternative treatments could be used interchangeably, and we highlighted no superiority between CFA and rFSH.

The current treatment regimen for ovarian stimulation in Intracytoplasmic sperm injection (ICSI) patients is daily injections of Gonadotropins. Recombinant DNA technologies have produced a new recombinant molecule that is a long-acting Follicle Stimulating Hormone (FSH), named corifollitropin alfa. A single injection of long-acting FSH can replace seven daily FSH injections during the first week of controlled ovarian stimulation (COS) and can make assisted reproduction more patients-friendly. There is limited data with different results in this area. To compare the effectiveness of long-acting FSH vs. daily r-FSH in terms of  pregnancy and safety outcomes in women undergoing ICSI cycles. In this clinical trial study, 109 women who were the candidates  for ICSI at azzahra hospital were divided in two groups. The first group received 150 units of daily Gonal-f from second or third day of menstruation. The second group received a 150IU corifollitropin alfa on the second or third day of mensuration, and the treatment continued from day eighth of stimulation with Gonal-f based on the ultrasound finding. Both the groups received GnRH antagonist from fifth day of stimulation. Two groups were compared in terms of number of dominantfollicles, number of oocytes, stimulation duration, total number of embryos, number of transferred embryos, and success rate of pregnancy. No significant difference was found between the two groups in terms of stimulation duration, number of follicles, number of oocytes, total number of embryos, and number of transferred embryos. Moreover, pregnancy outcomes including chemical pregnancy rate (positive pregnancy test), clinical pregnancy rate (detection of fetal heart), the rate of ovarian hyper-stimulation syndrome, multiple-pregnancy, ectopic pregnancy, and miscarriage didn’t have a significant difference between the two groups. As corifollitropin alfa was as effective as r-FSH, it could be used as an alternative to ovulation stimulation method in patients undergoing ICSI.