Highly purified versus recombinant FSH for ovarian stimulation in IVFICSI cycles

Abstract EN

Objective : to compare the efficacy and outcome in patients undergoing IVF / ICSI, using highly purified human urinary follicle stimulating hormone (HP-hFSH) versus human recombinant follitropin-alpha (rFSH) for ovarian stimulation protocols.

Design : Prospective, randomized controlled trial.

Setting : Assisted Reproduction Technology Unit, International Islamic Center for Population Studies & Research, Al-Azhar University.

Methods : 150 infertile patients undergoing a first attempt of IVF / ICSI were included in the study.

The inclusion criteria were : female age < 37 years, FSH < 10 IU / L, BMI < 30, without any uterine or ovarian pathology (no mommas or PCOS) and use of long protocol(luteal) GnRH agonist (GnRH-a) for pituitary down regulation.

All patients were randomized to HP-hFSH (n = 100) versus rFSH (n = 50) for ovarian stimulation.

Main Outcome Measures : primary endpoints were implantation rate, clinical pregnancy rate and spontaneous abortion rate.

Secondary end-points were total units of FSH injected, days of stimulation, peak estradiol levels at day of hCG administration, mean number of oocytes at pick-up, fertilization rate and Embryos of grade 1.

Results : in the r-FSH group there was both a significant reduction in the number of FSH ampoules required (20.7 ± 8.2 vs.

24,1 ± 7.7, p = 0.04) , a significantly increased number of oocytes collected at pick-up (12.9 ± 3.3 10.8 ± 4.1, p = 0.04),higher E2 at the day of hCG injection(2713.3 ± 595 vs.

2232.1 ±510,p=0.02) and more embryos suitable for cryo-preservation(5.8 ± 4.4 vs3.9 ± 3.3,p = 0.01).

Despite those finding, no statistically significant difference between the two groups were noted in the duration of stimulation(10.4 ± 1.4vs.

11.3 ± 0.9),number of coasted cycles, number of pre-ovulatory oocytes, endometrial thickness, fertilization rate(79 % vs.

77 %), embryos of grade 1 and mean number of embryo-transferred.

No statistically significantly differences in clinical outcome were found in the patients receiving HP-hFSH in comparison to patients receiving rFSH.

Conclusions : this study did not demonstrate a difference between the use of HP-hFSH vs rFSH for ovarian stimulation in terms of implantation rate, clinical pregnancy rate, spontaneous abortion rate and percentage of occurrence of Moderate / severe OHSS in good prognosis patients undergoing their first IVF / ICSI procedure.