Comparative Assessment of the Clinical Utility of Ovarian Stimulation With Menotropin Versus Menotropin Plus GnRH Antagonist
- Registration Number
- NCT01331733
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 131
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description hMG-HP hMG-HP Patients with a condition hMG-HP + GnRH antagonist hMG + GnRH antagonist Patients with a condition
- Primary Outcome Measures
Name Time Method Clinical pregnancy rate 30 days
- Secondary Outcome Measures
Name Time Method Live birth rate 40 weeks
Trial Locations
- Locations (1)
Investigational site
🇪🇸Valladolid, Spain