Main
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Note: This record shows only 22 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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03108963 |
Date of registration:
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06/04/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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L-carnitine and Metformin in Obese PCOS Women.
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Scientific title:
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L-carnitine Plus Metformin in Clomiphene-resistant Obese PCOS Women, Reproductive and Metabolic Effects: a Randomized Clinical Trial |
Date of first enrolment:
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January 2017 |
Target sample size:
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280 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03108963 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Egypt
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Contacts
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Name:
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ibrahim A el sharkwy, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- pco
- obese
- ifertile
Exclusion Criteria:
- no medical disorders
- no hormonal treatment in the previous 3 months
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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PCOS
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Intervention(s)
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Drug: placebo
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Drug: L-carnitine and Metformin
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Primary Outcome(s)
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pregnancy rate
[Time Frame: 3 momths]
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Secondary Outcome(s)
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insulin resistance
[Time Frame: 3 momths]
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lipid metabolism
[Time Frame: 3 momths]
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abortion rate
[Time Frame: 3 momths]
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ovulation rate
[Time Frame: 3 momths]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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