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

Ferring Pharmaceuticals1 site in 1 country131 target enrollmentNovember 2006

ConditionsSterility

InterventionshMG-HP hMG + GnRH antagonist

DrugshMG-HP hMG + GnRH antagonist

Overview

Phase: Not Applicable
Intervention: hMG-HP
Conditions: Sterility
Sponsor: Ferring Pharmaceuticals
Enrollment: 131
Locations: 1
Primary Endpoint: Clinical pregnancy rate
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2006

End Date

March 2009

Last Updated

15 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Ferring Pharmaceuticals

Eligibility 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