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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

131 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Sterility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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hMG-HP

Patients with a condition

hMG-HP

Intervention Type DRUG

hMG-HP + GnRH antagonist

Patients with a condition

hMG + GnRH antagonist

Intervention Type DRUG

Interventions

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hMG-HP

Intervention Type DRUG

hMG + GnRH antagonist

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No