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

NCT00669786 | Completed Phase 3

• 1 other identifier: VLC-EB-0103-0408-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Stimulation

Keywords

Ongoing Pregnancy Rate

Study Arms (2)

HMG

ACTIVE COMPARATOR

Human Menopausal Gonadotropin (HMG)

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

r-FSH

ACTIVE COMPARATOR

Recombinant Follicle Stimulating Hormone

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

Interventions

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

HMG; r-FSH

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Valenciano de Infertilidad, IVI VALENCIA: lead

Study Sites (1)

Instituto Valenciano de Infertilidad

Valencia, 46117, Spain

Location

Related Publications (1)

• Bosch E, Vidal C, Labarta E, Simon C, Remohi J, Pellicer A. Highly purified hMG versus recombinant FSH in ovarian hyperstimulation with GnRH antagonists--a randomized study. Hum Reprod. 2008 Oct;23(10):2346-51. doi: 10.1093/humrep/den220. Epub 2008 Jun 25.

  PMID: 18583332 DERIVED

MeSH Terms

Interventions

Menotropins; Glycoprotein Hormones, alpha Subunit

Intervention Hierarchy (Ancestors)

Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Biological Products; Complex Mixtures; Chorionic Gonadotropin; Follicle Stimulating Hormone; Luteinizing Hormone; Thyrotropin; Placental Hormones

Study Design

• Study Type: interventional
• Phase: phase 3
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 1, 2008
• Last Updated: May 1, 2008

Record last verified: 2008-04

Locations

ES (1)