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CompletedNCT01331733PROMENIAUpdated Apr 8, 2011

Comparative Assessment of the Clinical Utility of Ovarian Stimulation With Menotropin Versus Menotropin Plus GnRH Antagonist

An observational study in Sterility, sponsored by Ferring Pharmaceuticals. Completed at 7 sites in Spain. Open to female participants aged 18 Years to 36 Years. Per ClinicalTrials.gov, last updated 2011-04-08.

Sponsored by Ferring Pharmaceuticals · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
131
Ages
18 Years to 36 Years
Sex
Female
01

Study summary

To assess the effectiveness of protocols of ovarian hyperstimulation combining urinary gonadotrophins + GnRH antagonist vs urinary gonadotrophins, to achieve clinical pregnancy in females undergoing intrauterine insemination.

Study hypothesis: protocols combining urinary gonadotrophins + GnRH antagonist should be more effective than monotherapy.

02

Conditions studied

  • Sterility

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03

In context

Infertility

2,541 studies on the registry are indexed under Infertility; 405 are open to participants now.

This study's enrollment of 131 is below the median of 200 across 722 observational studies indexed under Infertility.

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Lead sponsor

Ferring Pharmaceuticals is the lead sponsor of 249 studies on the registry; 4 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 14 (93%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 36 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Females affected by sterility able to undergo intrauterine insemination

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women aged 18-36 years
  • Body mass index (BMI) between 18 and 26
  • Prolactin within the laboratory normal range
  • Couples affected by sterility able to treat by IUI (intrauterine insemination)
  • Patients undergoing Menopur® treatment
  • Normal thyroid function
  • Regular menses (21-35 days)
  • Couples willing to participate in the study that have signed the informed consent form
  • Seminal sample REM>3 million

Exclusion criteria

Exclusion Criteria:

  • Two previous ART (assisted reproductive technology) cycles without ongoing pregnancy
  • Policystic ovarian syndrome
  • Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
131 participants (actual)

Groups and cohorts

  • hMG-HP

    Patients with a condition

    Drug: hMG-HP

  • hMG-HP + GnRH antagonist

    Patients with a condition

    Drug: hMG + GnRH antagonist

Interventions

  • DrughMG-HP
  • DrughMG + GnRH antagonist
06

What researchers measure

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: 30 days

Secondary outcomes

  1. Live birth rate

    Time frame: 40 weeks

07

Study locations

7 sites
  • Investigational site
    Barcelona, Barcelona, Spain
  • Investigational site
    Ciudad Real, Ciudad Real, Spain
  • Investigational site
    Girona, Gerona, Spain
  • Investigational site
    La Rioja, La Rioja, Spain
  • Investigational site
    Navarra, Navarre, Spain
  • Investigational site
    Reus, Tarragona, Spain
  • Investigational site
    Valladolid, Valladolid, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01331733
Collaborators
Ferring SAU
First posted
Apr 8, 2011
Start date
Nov 2006
Primary completion
Oct 2008
Completion
Mar 2009
Last update
Apr 8, 2011

Study contacts

Clinical Development Support
study director · Ferring Pharmaceuticals

Oversight

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

Not currently enrolling

This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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