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

May 30, 2021 updated by: Asmaa Abdelbadea Ali Salih, Ain Shams University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

400

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams Univerisity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Asmaa Salih, Resident, Ainshams university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2018

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

March 30, 2021

Study Registration Dates

First Submitted

May 26, 2018

First Submitted That Met QC Criteria

June 20, 2018

First Posted (Actual)

June 25, 2018

Study Record Updates

Last Update Posted (Actual)

June 2, 2021

Last Update Submitted That Met QC Criteria

May 30, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AinShamaU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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