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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01331733
Acronym
PROMENIA
Enrollment
131
Registered
2011-04-08
Start date
2006-11-30
Completion date
2009-03-31
Last updated
2011-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sterility

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.

Interventions

DRUGhMG-HP
DRUGhMG + GnRH antagonist

Sponsors

Ferring SAU
CollaboratorINDUSTRY
Ferring Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 36 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy rate30 days

Secondary

MeasureTime frame
Live birth rate40 weeks

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026