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

Phase 3

Completed

• Conditions: Ovarian Stimulation
• Interventions: Drug: Human Menopausal Gonadotropin (HMG) & - Recombinant Follicle Stimulating Hormone (r-FSH)

• Registration Number: NCT00669786
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-04
• Study First Submitted: 2008-04-29
• Study First Submitted QC: 2008-04-30
• Last Update Submitted: 2008-04-30
• Study First Posted: 2008-05-01
• Last Update Posted: 2008-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HMG	Human Menopausal Gonadotropin (HMG) & - Recombinant Follicle Stimulating Hormone (r-FSH)	Human Menopausal Gonadotropin (HMG)
r-FSH	Human Menopausal Gonadotropin (HMG) & - Recombinant Follicle Stimulating Hormone (r-FSH)	Recombinant Follicle Stimulating Hormone

Trial Locations

Locations (1)

Instituto Valenciano de Infertilidad; 🇪🇸 Valencia, Spain