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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.
Information provided by:
Instituto Valenciano de Infertilidad, IVI VALENCIA Identifier:
First received: April 29, 2008
Last updated: April 30, 2008
Last verified: April 2008
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:

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

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)


Ages Eligible for Study:   18 Years to 37 Years   (Adult)
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.
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Please refer to this study by its identifier: NCT00669786

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

Publications automatically indexed to this study by Identifier (NCT Number): 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

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

Additional relevant MeSH terms:
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents processed this record on May 25, 2017