Sterility Clinical Trial
— PROMENIAOfficial 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
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.
Status | Completed |
Enrollment | 131 |
Est. completion date | March 2009 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 36 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
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 | Reus | Tarragona |
Spain | Investigational site | Valladolid |
Lead Sponsor | Collaborator |
---|---|
Ferring Pharmaceuticals | Ferring SAU |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical pregnancy rate | 30 days | No | |
Secondary | Live birth rate | 40 weeks | No |
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