IVF Outcomes with Either Highly Purified FSH vs. Recombinant FSH in Down-Regulated Normogonadotrophic Women: A Prospective Comparative Study in a Developing Country and Meta-Analysis

Objective: In order to compare the use of highly purified (HP) follicle stimulating hormone (FSH) with recombinant FSH (recFSH) in a developing country, research should not only focus on clinical data, but also on the evidence available in the literature from previous trials. Study Design:We performed a prospective clinical trial with 118 infertile females undergoing IVF: HP-FSH (n = 59); recFSH (n = 59).In addition, we performed a meta-analysis of RCTs comparing currently available HP-FSH vs. recFSH.The primary outcomes for both studies were live-birth rate and rate of ovarian hyperstimulation.Results: In the clinical trial, the response to ovarian hyperstimulation was similar in both groups including the number of oocytes retrieved and the number of ampoules of gonadotrophins.The live birth rate per woman was 30.51% vs. 35.59% in the HP-FSH and recFSH treated groups respectively (P = 0.70).The rate of OHSS was 5.09% in the HP-FSH compared to 6.78% in the recFSH treated groups (P = 1.00).Regarding the meta-analysis, the live-birth (O.R= 1.30, 95% CI= 0.92 to 1.84) and OHSS rates (O.R= 1.14, 95% CI= 0.32 to 4.04) were not significantly different between the two groups.There was significantly less treatment days and total dose (IU) in the HP-FSH group compared with the rFSH group.Conclusion: HP-FSH yields similar clinical outcome to recFSH in terms of oocytes retrieved and live-birth rate.