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

Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA (Other)
Overall Status
Completed
CT.gov ID
NCT00669786
Collaborator
(none)
1
Location
2
Arms

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Human Menopausal Gonadotropin (HMG) & - Recombinant Follicle Stimulating Hormone (r-FSH)
 Phase 3

Study Design

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

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: HMG

Human Menopausal Gonadotropin (HMG)

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

Recombinant Follicle Stimulating Hormone

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 37 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto Valenciano de Infertilidad Valencia Spain 46117

    Sponsors and Collaborators

    • Instituto Valenciano de Infertilidad, IVI VALENCIA

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00669786
    Other Study ID Numbers:
    • VLC-EB-0103-0408-1
    First Posted:
    May 1, 2008
    Last Update Posted:
    May 1, 2008
    Last Verified:
    Apr 1, 2008
    Keywords provided by , ,
    Ongoing Pregnancy Rate
    Additional relevant MeSH terms:
    Menotropins
    Hormones
    Follicle Stimulating Hormone

    Study Results

    No Results Posted as of May 1, 2008