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

Study Overview
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Brief Summary
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Participants with PCOS will be divided into two groups then each group will randomly recieve one of the following treatment metformin will be adminstered in adose of 500 mg 3 times daily for 3 months to group B. pioglitazone will be administered in adose of 30 mg dialy for 3 months to group A. Induction of ovulation by clomiphene citate 50 mg tablets to all participants

Detailed Description
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Participants with PCOS will be divided into two groups then each group will randomly recieve one of the following treatment metformin will be adminstered in adose of 500 mg 3 times daily for 3 months to group B. pioglitazone will be administered in adose of 30 mg dialy for 3 months to group A. 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

Official Title
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Combined Pioglitazone and Clomophene Citrate Versus Combined Metformin and Clomiphene Citrate as First Treatment in Infertile Women With Polycystic Ovary Syndrome

Conditions
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Pioglitazone

Intervention / Treatment
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* Drug: Pioglitazone
* Drug: Metformin
* Drug: Clomiphene Citrate


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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Pioglitazone in adose 30 mg tablet will be administered dialy+ clomiphene citrate as ovulation induction | Drug: Pioglitazone<br>* Insulin sensitizing agents<br>* Other names: Glustazon;Drug: Clomiphene Citrate<br>* Induction drug<br>* Other names: Clomid;|
| Placebo Comparator: Group B<br>Metformin in adose 1500 mg dialy will be administered + clomiphene citrate | Drug: Metformin<br>* Insulin sensitizing agent<br>* Other names: Cidophage;Drug: Clomiphene Citrate<br>* Induction drug<br>* Other names: Clomid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Pregnancy rate diagnosed by U/S at five weeks after missed menses | 3 months |