Pioglitazone Versus Metformin as First Treatment in Infertile Women With Polycystic Ovary Syndrome
NCT ID: NCT03566225
Last Updated: 2021-06-02
Study Results
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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COMPLETED
EARLY_PHASE1
400 participants
INTERVENTIONAL
2018-01-30
2021-03-30
Brief Summary
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1. metformin will be adminstered in adose of 500 mg 3 times daily for 3 months to group B.
2. pioglitazone will be administered in adose of 30 mg dialy for 3 months to group A.
3. Induction of ovulation by clomiphene citate 50 mg tablets to all participants
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Detailed Description
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1. metformin will be adminstered in adose of 500 mg 3 times daily for 3 months to group B.
2. pioglitazone will be administered in adose of 30 mg dialy for 3 months to group A.
3. Induction of ovulation by clomiphene citate 50 mg tablets once or twice dialy 12hours apart starting from the 3rd day of menstrual cycle and continue for five days during treatment with insulin sensitizing agents to group A and B.
Participants with oligomenorrhea will recieve two tablets of noreththisterone 5 mg tab every 12 hours for 5 days to allow for withdrawal bleeding before start ovulation induction
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Group A
Pioglitazone in adose 30 mg tablet will be administered dialy+ clomiphene citrate as ovulation induction
Pioglitazone
Insulin sensitizing agents
Clomiphene Citrate
Induction drug
Group B
Metformin in adose 1500 mg dialy will be administered + clomiphene citrate
Metformin
Insulin sensitizing agent
Clomiphene Citrate
Induction drug
Interventions
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Pioglitazone
Insulin sensitizing agents
Metformin
Insulin sensitizing agent
Clomiphene Citrate
Induction drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI 18\_29.9
* Women with PCOS(diagnosed by using Rotterdam criteria
* Infertility is cause for seeking tfeatment
Exclusion Criteria
* patient refusal.
* Contraindication of any of the drugs used in the study
* Cause of oligo/anovulation other than PCOS
* Current or previous (within the last six month) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetics, antiobesity drugs or other hormonal drugs.
20 Years
35 Years
FEMALE
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Asmaa Abdelbadea Ali Salih
Cairo
Principal Investigators
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Asmaa Salih, Resident
Role: PRINCIPAL_INVESTIGATOR
AinShams University
Locations
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Ain Shams Univerisity
Cairo, , Egypt
Countries
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Other Identifiers
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AinShamaU
Identifier Type: -
Identifier Source: org_study_id
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