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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03566225
Enrollment
400
Registered
2018-06-25
Start date
2018-01-30
Completion date
2021-03-30
Last updated
2021-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pioglitazone

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

Interventions

DRUGPioglitazone

Insulin sensitizing agents

DRUGMetformin

Insulin sensitizing agent

DRUGClomiphene Citrate

Induction drug

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical pregnancy rate3 monthsPregnancy rate diagnosed by U/S at five weeks after missed menses

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026