CClinicalTrials.gg
Sign In
CompletedNCT00669786Updated May 1, 2008

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

A Phase 3 interventional study of Human Menopausal Gonadotropin (HMG) & - Recombinant Follicle Stimulating Hormone (r-FSH) in Ovarian Stimulation, sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA. Completed at 1 site in Spain. Open to female participants aged 18 Years to 37 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-05-01.

Sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Ages
18 Years to 37 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Ovarian Stimulation

Keywords

  • Ongoing Pregnancy Rate
03

In context

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA is the lead sponsor of 70 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 37 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 3

Study arms

  • 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)

Interventions

  • DrugHuman Menopausal Gonadotropin (HMG) & - Recombinant Follicle Stimulating Hormone (r-FSH)
06

Study locations

1 site
  • Instituto Valenciano de Infertilidad
    Valencia, 46117, Spain
07

References and documents

Publications

  • 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. PubMed 18583332 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00669786
Lead sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
First posted
May 1, 2008
Last update
May 1, 2008

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Start the discussion