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OpenTrials
Completed

NCT Number: NCT01331733

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

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.

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Key information

Conditions

Sterility Genital Diseases Infertility Urogenital Diseases

Age range

18 year–36 year

Sex eligibility

Female

Study type

Observational

Primary location

Investigational site, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hMG-HP

Drug

hMG + GnRH antagonist

Drug

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: 30 days

Secondary outcomes

  1. Live birth rate

    Time frame: 40 weeks

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Collaborators

  • Ferring SAU

Registry information

Official study 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

Acronym: PROMENIA

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Apr 8, 2011
Registry last updated
Apr 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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