Insulin Sensitizers Role in Control of PCOS Vicious Cycle.
NCT ID: NCT06170463
Last Updated: 2023-12-20
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
PHASE1
210 participants
INTERVENTIONAL
2022-08-01
2023-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Met Group
Metformin Hydrochloride
Met Group Received metformin hydrochloride 500 mg tab 3 times Daily
MI Group
MI/DCI combination in 40:1 ratio
MI-group received MI/DCI combination in 40:1 ratio twice daily
MM Group
Combination of Metformin hydrochloride and MI/DCI
MM Group Received both Met and MI Groups Treatment
Interventions
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Metformin Hydrochloride
Met Group Received metformin hydrochloride 500 mg tab 3 times Daily
MI/DCI combination in 40:1 ratio
MI-group received MI/DCI combination in 40:1 ratio twice daily
Combination of Metformin hydrochloride and MI/DCI
MM Group Received both Met and MI Groups Treatment
Eligibility Criteria
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Inclusion Criteria
* Residence;
* level of education \& type of work;
* Marital and fertility statuses, and if infertility was the main complaint;
* Presence of risk factors as sedentary lifestyle;
* Emotional stress and family history of PCOS;
* Obesity-related medical disorders especially DM or MAFLD;
* History of previous treatment for PCOS and its outcomes;
* Menstrual pattern such as infrequent menstrual periods.
Exclusion Criteria
* Cardiac manifestations of PCOS;
* Maintained on other therapies or prepared for /received laparoscopic intervention for PCOS;
* Receiving scheduled exercise, lipid-lowering therapies, or maintained on diabetogenic drugs for any other indications;
* Had morbid obesity with body mass index (BMI) \>35 kg/m2;
* Causes other than PCOS for infertility, manifest DM, hepatic or pancreatic diseases.
18 Years
45 Years
FEMALE
No
Sponsors
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Zagazig University
OTHER_GOV
Responsible Party
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Walid Mohamed Elnagar
Assistant professor of gynecology
Locations
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Zagazig university
Zagazig, Ash Sharqia Governorate, Egypt
Countries
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Other Identifiers
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ZU-IRB#11195-21/6-2023
Identifier Type: -
Identifier Source: org_study_id
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