Fixed-dose of recombinant follicle stimulating hormone (200 IU vs 300 IU) in indian women undergoing intracytoplasmic sperm injection: a comparative study

Abstract

OBJECTIVE: There are few studies in Indian populations with different doses of recombinant follicle-stimulating hormone (rFSH) for controlled ovarian stimulation (COS). Hence, this study was planned to compare the efficacy of two (fixed) doses of rFSH in COS protocol. DESIGN: An open label, prospective, randomized study comparing the effect of 200 IU or 300 IU daily fixed-dose of rFSH in women undergoing intracytoplasmic sperm injection (ICSI). MATERIALS AND METHODS: 59 female subjects (aged between 25-30 years), undergoing 1st cycle for treatment of male factor infertility, with normal cycles (mean length between 24 and 35 days) and body mass index of 18 to <30 kg/m2 were enrolled. Eligible subjects following down regulation with Lupride from day 21, received either 200 IU or 300 IU of daily dose of rFSH (Recagon; Organon) starting from 2nd/3rd day of the period according to the randomization. On the 6th day of stimulation, 150 IU of Human Menopausal Gonadotropin (hMG) (Menopur; Ferring) was added if there were <5 follicles of 10 mm in both ovaries combined. Human chorionic gonadotropin (hCG) was administered with >4 follicles of ≥18 mm diameter and endometrial thickness of >8 mm. Ovum pick-up was done 35 hours after hCG injection followed by luteal support with progesterone. The primary end points were number of cumulus-oocyte complexes, total dose of rFSH used, ongoing clinical pregnancy and implantation rates. Secondary end points were treatment length, the number of follicles (on the day of hCG administration), mature oocytes, good quality embryos, percentage of patients requiring hMG, incidence of ovarian hyperstimulation syndrome (OHSS), cancellation and clinical pregnancy rate. RESULTS: A total of 59 women were treated with 200 IU (n=28) and 300 IU (n=31) of rFSH. In comparison to 300 IU, the 200 IU treated group had a higher number of cumulus-oocyte complexes retrieved (16.0 vs 10.9; p<0.01), lesser rFSH used (2014 vs 3029 IU; p<0.001), comparable implantation rate (19.7% vs 8.6%; NS) and comparable ongoing clinical pregnancy rates per started cycle (32.1% vs 16.1%; NS). A significantly higher number of matured oocytes (14.2 vs 9.2, P<0.01) and good quality embryos (8.6 vs 5.5; P<0.01) were retrieved in 200 IU group as compared to 300 IU group. CONCLUSIONS: Current study suggests that the use of a lower dose (200 IU) instead of a higher dose (300 IU) of rFSH, in Indian infertile women, may offer equivalent benefits.