Pioglitazone Versus Metformin as First Treatment in Infertile Women With Polycystic Ovary Syndrome

Early Phase 1

Completed

• Conditions: Pioglitazone
• Interventions: Drug: Pioglitazone; Drug: Metformin; Drug: Clomiphene Citrate

• Registration Number: NCT03566225
• Lead Sponsor: Ain Shams University

Brief Summary

Participants with PCOS will be divided into two groups then each group will randomly recieve one of the following treatment

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

Detailed Description

Participants with PCOS will be divided into two groups then each group will randomly recieve one of the following treatment

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

Study Timeline

• Study Start: 2018-01-30
• Study First Submitted: 2018-05-26
• Study First Submitted QC: 2018-06-20
• Study First Posted: 2018-06-25
• Primary Completion: 2021-02-28
• Study Completion: 2021-03-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-30
• Last Update Posted: 2021-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• women age 20_35
• BMI 18_29.9
• Women with PCOS(diagnosed by using Rotterdam criteria
• Infertility is cause for seeking tfeatment

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Exclusion Criteria

• Causes of infertility other than PCOS.
• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A	Pioglitazone	Pioglitazone in adose 30 mg tablet will be administered dialy+ clomiphene citrate as ovulation induction
Group A	Clomiphene Citrate	Pioglitazone in adose 30 mg tablet will be administered dialy+ clomiphene citrate as ovulation induction
Group B	Metformin	Metformin in adose 1500 mg dialy will be administered + clomiphene citrate
Group B	Clomiphene Citrate	Metformin in adose 1500 mg dialy will be administered + clomiphene citrate

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	3 months	Pregnancy rate diagnosed by U/S at five weeks after missed menses

Trial Locations

Locations (1)

Ain Shams Univerisity; 🇪🇬 Cairo, Egypt