Corifollitropin- α compared to daily r-FSH in for patients undergoing intracytoplasmic sperm injection: Clinical trial study.

Zahiri Sorouri Z, Pourmarzi D, Safar Khah N
International journal of reproductive biomedicine · 2019 · doi:10.18502/ijrm.v17i1.3817 · PMID:31435581 · PMC6652158
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This clinical trial found no significant differences in stimulation duration, oocyte yield, or pregnancy outcomes between women receiving corifollitropin alfa versus daily recombinant FSH during intracytoplasmic sperm injection cycles.

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This randomized clinical trial compared the efficacy of a single injection of long-acting corifollitropin alfa against daily recombinant FSH (Gonal-f) in 109 women undergoing intracytoplasmic sperm injection. The study found no significant differences between the two groups regarding stimulation duration, follicle count, oocyte yield, embryo quality, or clinical pregnancy rates. While the authors note that previous literature lacks consensus on optimal dosing and patient selection criteria, their results indicate that the long-acting formulation is equally effective to the daily regimen for this population. Relevance to endometriosis: patients with stage III or IV endometriosis were explicitly excluded from the study cohort, meaning the findings do not apply to those with moderate to severe disease.

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Abstract

BackgroundThe 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.ObjectiveTo compare the effectiveness of long-acting FSH vs. daily r-FSH in terms of pregnancy and safety outcomes in women undergoing ICSI cycles.Materials and methodsIn 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 dominant follicles, number of oocytes, stimulation duration, total number of embryos, number of transferred embryos, and success rate of pregnancy.ResultsNo 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.ConclusionAs corifollitropin alfa was as effective as r-FSH, it could be used as an alternative to ovulation stimulation method in patients undergoing ICSI.
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Considering the fact that frequent injections of daily Gonal-F increase the risk of incorrect injection and it can affect the IVF outcome, using a drug with fewer injections and a single dose can resolve this problem. On the other hand, frequent injections increase the patients' stress and it can affect the treatment process and IVF outcome. Thus, corifollitropin alfa can be a good alternative for frequent injections. However, a study with wider dimensions and with larger sample size should be performed for better analysis and investigation.

Coi Statement

The authors declare that they have no conflicts of interest.

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