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

Ovarian Stimulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00669786
• Other study ID #: VLC-EB-0103-0408-1
• Status: Completed
• Phase: Phase 3
• First received: April 29, 2008
• Last updated: April 30, 2008

Study information

• Verified date: April 2008
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Ovarian Stimulation

Intervention

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

Locations

Country	Name	City	State
Spain	Instituto Valenciano de Infertilidad	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain,