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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: |
NCT01233206 |
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Date of registration:
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08/10/2010 |
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Primary sponsor: |
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Public title:
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Metformin in High Responder Polycystic Ovary Syndrome (PCOS) Patients Undergoing IVF Cycles
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Scientific title:
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Metformin Addition to Gonadotropins Ovarian Stimulation in High Responder Patients With PCOS Undergoing In-vitro Fertilization |
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Date of first enrolment:
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May 2009 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01233206 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Italy
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Contacts
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Name:
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Fulvio Zullo |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Magna Graecia |
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Name:
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Stefano Palomba |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Magna Graecia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- History of one previous cancelled cycle for high-risk of OHSS, or history of
moderate/severe OHSS during their previous IVF cycle
- Infertility
- Polycystic ovary syndrome (PCOS)
- insulin resistance
- hyperandrogenism
Exclusion Criteria:
- BMI>30 kg/m2
- age >35 years
- FSH>9UI/L
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Infertility
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Polycystic Ovary Syndrome (PCOS)
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Intervention(s)
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Drug: Metformin
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Drug: Placebo administration
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Primary Outcome(s)
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Rate of OHSS
[Time Frame: one month]
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Secondary Outcome(s)
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Dominant follicles on day of ovulation triggering
[Time Frame: one month]
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Embryo quality
[Time Frame: one month]
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Gonadotropins dose
[Time Frame: one month]
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Live birth rate
[Time Frame: ten months]
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multiple pregnancy rate
[Time Frame: one month]
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Ovulation rate
[Time Frame: one month]
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Peak estradiol levels on day of ovulation triggering
[Time Frame: one month]
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pregnancy rate
[Time Frame: one month]
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Stimulation length
[Time Frame: one month]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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