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

Pioglitazone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566225
• Other study ID #: AinShamaU
• Status: Completed
• Phase: Early Phase 1
• Start date: January 30, 2018
• Est. completion date: March 30, 2021

Study information

• Verified date: May 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 30, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pioglitazone
• Polycystic Ovary Syndrome

Intervention

Drug:
• Pioglitazone
Insulin sensitizing agents
• Metformin
Insulin sensitizing agent
• Clomiphene Citrate
Induction drug

Locations

Country	Name	City	State
Egypt	Ain Shams Univerisity	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Pregnancy rate diagnosed by U/S at five weeks after missed menses	3 months