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

Primary Purpose

Pioglitazone

Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Pioglitazone
Metformin
Clomiphene Citrate
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pioglitazone

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts 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.

Sites / Locations

  • Ain Shams Univerisity

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinical pregnancy rate
Pregnancy rate diagnosed by U/S at five weeks after missed menses

Secondary Outcome Measures

Full Information

First Posted
May 26, 2018
Last Updated
May 30, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03566225
Brief Title
Pioglitazone Versus Metformin as First Treatment in Infertile Women With Polycystic Ovary Syndrome
Official Title
Combined Pioglitazone and Clomophene Citrate Versus Combined Metformin and Clomiphene Citrate as First Treatment in Infertile Women With Polycystic Ovary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 30, 2018 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

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

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pioglitazone

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Pioglitazone in adose 30 mg tablet will be administered dialy+ clomiphene citrate as ovulation induction
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
Metformin in adose 1500 mg dialy will be administered + clomiphene citrate
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Other Intervention Name(s)
Glustazon
Intervention Description
Insulin sensitizing agents
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Cidophage
Intervention Description
Insulin sensitizing agent
Intervention Type
Drug
Intervention Name(s)
Clomiphene Citrate
Other Intervention Name(s)
Clomid
Intervention Description
Induction drug
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Pregnancy rate diagnosed by U/S at five weeks after missed menses
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asmaa Salih, Resident
Organizational Affiliation
AinShams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams Univerisity
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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