Human Menopausal Gonadotropin (HMG) vs Recombinant Follicle Stimulating Hormone (rFSH) in Gonadotropin Releasing Hormone (GnRH) Antagonist Cycles
Information source: Instituto Valenciano de Infertilidad, Spain
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ovarian Stimulation
Intervention: Human Menopausal Gonadotropin (HMG) & - Recombinant Follicle Stimulating Hormone (r-FSH) (Drug)
Phase: Phase 3
Sponsored by: Instituto Valenciano de Infertilidad, Spain
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.
Official title: Highly Purified Human Menopausal Gonadotropin Versus Recombinant Follicle Stimulating Hormone in Ovarian Hyperstimulation With Gonadotropin Releasing Hormone Antagonists. A Randomized Study.
Study design: N/A
Minimum age: 18 Years.
Maximum age: 37 Years.
- 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 (â‰¤ 10 IU/L) and E2 (â‰¤ 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
- 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.
Locations and Contacts
Instituto Valenciano de Infertilidad, Valencia 46117, Spain
Last updated: April 30, 2008