Human Menopausal Gonadotropin (HMG) vs Recombinant Follicle Stimulating Hormone (rFSH) in Gonadotropin Releasing Hormone (GnRH) Antagonist Cycles

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

A randomized controlled trial comparing the ongoing pregnancy rate (primary end-point) in 280 patients undergoing IVF/ICSI after stimulation with hp-hMG or rFSH controlled with a GnRH antagonist. Non significant differences were observed between hp-hMG and rFSH in terms of the ongoing pregnancy rate per started cycle (35.0% vs. 32.1%; p=0.61); R.R: 1.09 (95% CI: 0.78-1.51; Risk Difference: 2.9%). No differences were observed for implantation, clinical pregnancy and pregnancy loss rates. Patients receiving rFSH obtained more oocytes (14.4 ± 8.1 vs. 11.3 ± 6.0; p=0.001). Estradiol was higher at the end of stimulation in the hp-hMG group, while Progesterone was higher in patients stimulated with rFSH.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Treatments: Follicle Stimulating Hormone; Hormones; Menotropins

Criteria

Inclusion Criteria:

• women with good physical and mental health

• aged 18-37 years

• regular menstrual cycles ranging from 25 to 35 days; body mass index (BMI) < 30 kg/m2

• normal basal serum FSH (≤ 10 IU/L) and E2 (≤ 75 pg/mL) levels determined on the day 3 of the cycle previous to COH

• no uterine (fibroids, adenomyosis, mullerian malformations), ovarian (endometrioma, polycystic ovaries) or adnexa (hydrosalpinx) abnormalities assessed by vaginal ultrasound.

Exclusion Criteria:

• patients with a history of recurrent pregnancy loss

• any significant systemic disease, endocrine or metabolic disorder

• having concomitant medication interfering with the purposes of the study

• patients who have received any ovulation induction drug within one month before their inclusion in the study.