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

Ferring

Status: Completed

Conditions: Sterility

Treatments: Drug: hMG + GnRH antagonist; Drug: hMG-HP

Study type: Observational

Funder types: Industry

Identifiers

NCT01331733

FER-MEN-2006-01

Details and patient eligibility

About

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.

Enrollment: 131 patients

Sex: Female

Ages: 18 to 36 years old

Volunteers: No Healthy Volunteers

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

Trial design

131 participants in 2 patient groups

hMG-HP

Description:

Patients with a condition

Treatment:

Drug: hMG-HP

hMG-HP + GnRH antagonist

Description:

Patients with a condition

Treatment:

Drug: hMG + GnRH antagonist