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

This study has been completed.
Sponsor:
Collaborator:
Ferring SAU
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01331733
First received: April 6, 2011
Last updated: April 7, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention
Sterility
 Drug: hMG-HP
Drug: hMG + GnRH antagonist

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Assessment of the Clinical Utility of Ovarian Stimulation With Menotropin Versus Menotropin Plus GnRH Antagonist Following Two Protocols of Ovulation Induction for Intrauterine Insemination

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Live birth rate [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]

Enrollment: 131
Study Start Date: November 2006
Study Completion Date: March 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
hMG-HP
Patients with a condition
 Drug: hMG-HP
hMG-HP + GnRH antagonist
Patients with a condition
 Drug: hMG + GnRH antagonist

  Eligibility

Ages Eligible for Study:   18 Years to 36 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Females affected by sterility able to undergo intrauterine insemination

Criteria

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:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331733

Locations
Spain
Investigational site
Reus, Tarragona, Spain
Investigational site
Barcelona, Spain
Investigational site
Ciudad Real, Spain
Investigational site
Gerona, Spain
Investigational site
La Rioja, Spain
Investigational site
Navarra, Spain
Investigational site
Valladolid, Spain
Sponsors and Collaborators
Ferring Pharmaceuticals
Ferring SAU
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01331733     History of Changes
Other Study ID Numbers: FER-MEN-2006-01
Study First Received: April 6, 2011
Last Updated: April 7, 2011
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Menotropins
Fertility Agents, Female
 Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013