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

Ain Shams University

Status and phase: Completed; Early Phase 1

Conditions: Pioglitazone

Treatments: Drug: Metformin; Drug: Pioglitazone; Drug: Clomiphene Citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT03566225

AinShamaU

Details and patient eligibility

About

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

Full 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

Enrollment: 400 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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400 participants in 2 patient groups, including a placebo group

Group A

Active Comparator group

Description:

Pioglitazone in adose 30 mg tablet will be administered dialy+ clomiphene citrate as ovulation induction

Treatment:

Drug: Clomiphene Citrate

Drug: Pioglitazone

Group B

Placebo Comparator group

Description:

Metformin in adose 1500 mg dialy will be administered + clomiphene citrate

Treatment:

Drug: Clomiphene Citrate

Drug: Metformin