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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03268733 |
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Date of registration:
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24/08/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome
FolicacidPCOS |
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Scientific title:
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The Clinical and Biochemical Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome (PCOS) |
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Date of first enrolment:
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September 1, 2017 |
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Target sample size:
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90 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03268733 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Sudan
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Contacts
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Name:
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Mohammed Hassan Alnazeer |
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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 of Khartoum |
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Name:
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Mohammed ibrahim Awad |
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Address:
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Telephone:
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00249900904060 |
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Email:
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awad22mohd@gmail.com |
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Affiliation:
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Name:
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Mohammed Hassan Alnazeer |
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Address:
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Telephone:
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00249912907268 |
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Email:
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mhmd_nazir83@yahoo.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients who will visit this centre suffering from PCOS-related subfertility will be
invited to be enrolled to this study if met the Rotterdam criteria for the diagnosis
of PCOS
Exclusion Criteria:
- The patients whom will be excluded from the study are those comorbid with
hyperprolactinemia, congenital adrenal hyperplasia, diabetes mellitus, significant
cardiovascular problems, thyroid dysfunctions, unresolved medical conditions, or using
medications suspected to affect reproductive or metabolic functions within two months
of the study entry.
Age minimum:
20 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Polycystic Ovary Syndrome
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Intervention(s)
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Drug: Folic Acid
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Primary Outcome(s)
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pregnancy rates
[Time Frame: 3 months]
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Clinical signs of hyperandrogenemia
[Time Frame: 3 months]
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Ovulatory pattern improvements
[Time Frame: 3 months]
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Secondary Outcome(s)
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Plasma level of follicle-stimulating hormone (FSH)
[Time Frame: 3 months]
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Plasma level of insulin
[Time Frame: 3 months]
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Plasma level of luteinizing hormone (LH)
[Time Frame: 3 months]
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Plasma level of testosterone
[Time Frame: 3 months]
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Secondary ID(s)
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Folic acid in PCOS
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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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