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

This study has been completed.
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT00669786
First received: April 29, 2008
Last updated: April 30, 2008
Last verified: April 2008
History of Changes
  Purpose

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 Intervention Phase
Ovarian Stimulation
 Drug: Human Menopausal Gonadotropin (HMG) & - Recombinant Follicle Stimulating Hormone (r-FSH)
 Phase 3

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.

Resource links provided by NLM:

MedlinePlus related topics: Menopause
U.S. FDA Resources

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 37 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669786

Locations
Spain
Instituto Valenciano de Infertilidad
Valencia, Spain, 46117
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
  More Information

No publications provided by Instituto Valenciano de Infertilidad, Spain

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00669786     History of Changes
Other Study ID Numbers: VLC-EB-0103-0408-1
Study First Received: April 29, 2008
Last Updated: April 30, 2008
Health Authority: Spain: Ethics Committee

Keywords provided by Instituto Valenciano de Infertilidad, Spain:
Ongoing Pregnancy Rate

Additional relevant MeSH terms:
Hormone Antagonists
Hormones
Follicle Stimulating Hormone
Menotropins
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
 Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013