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

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status and phase

Completed

Phase 3

Conditions

Ovarian Stimulation

Treatments

Drug: Human Menopausal Gonadotropin (HMG) & - Recombinant Follicle Stimulating Hormone (r-FSH)

Study type

Interventional

Funder types

Other

Identifiers

NCT00669786

VLC-EB-0103-0408-1

Details and patient eligibility

About

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.

Sex

Female

Ages

18 to 37 years old

Volunteers

Accepts Healthy Volunteers

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.