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

Sterility Clinical Trial

— PROMENIA  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331733
• Other study ID #: FER-MEN-2006-01
• Status: Completed
• Phase: N/A
• First received: April 6, 2011
• Last updated: April 7, 2011
• Start date: November 2006
• Est. completion date: March 2009

Study information

• Verified date: April 2011
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sterility

Intervention

Drug:
• hMG-HP

• hMG + GnRH antagonist

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals	Ferring SAU

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate		30 days	No
Secondary	Live birth rate		40 weeks	No