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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01331733 |
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Date of registration:
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06/04/2011 |
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Primary sponsor: |
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Public title:
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Comparative Assessment of the Clinical Utility of Ovarian Stimulation With Menotropin Versus Menotropin Plus GnRH Antagonist
PROMENIA |
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Scientific title:
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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 |
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Date of first enrolment:
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November 2006 |
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Target sample size:
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131 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01331733 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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Spain
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Contacts
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Name:
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Clinical Development Support |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ferring Pharmaceuticals |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
36 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Sterility
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Intervention(s)
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Drug: hMG + GnRH antagonist
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Drug: hMG-HP
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Primary Outcome(s)
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Clinical pregnancy rate
[Time Frame: 30 days]
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Secondary Outcome(s)
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Live birth rate
[Time Frame: 40 weeks]
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Secondary ID(s)
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FER-MEN-2006-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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