Official Title: “Highly Purified Human Menopausal Gonadotropin Versus Recombinant Follicle Stimulating Hormone in Ovarian Hyperstimulation With Gonadotropin Releasing Hormone Antagonists. A Randomized Study.”

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.

Study Type: Interventional

Study Design: N/A

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: HMG
  • Human Menopausal Gonadotropin (HMG)
• Active Comparator: r-FSH
  • Recombinant Follicle Stimulating Hormone

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 37 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Instituto Valenciano de Infertilidad, Spain

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00669786

Study ID Number: VLC-EB-0103-0408-1

ClinicalTrials.gov Identifier: NCT00669786

Health Authority: Spain: Ethics Committee