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

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT03566225
Collaborator
(none)
400
Enrollment
1
Location
2
Arms
37.9
Actual Duration (Months)
10.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Combined Pioglitazone and Clomophene Citrate Versus Combined Metformin and Clomiphene Citrate as First Treatment in Infertile Women With Polycystic Ovary Syndrome
Actual Study Start Date :
Jan 30, 2018
Actual Primary Completion Date :
Feb 28, 2021
Actual Study Completion Date :
Mar 30, 2021

Arms and Interventions

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: Metformin
    Insulin sensitizing agent
    Other Names:
  • Cidophage

    • Drug: Clomiphene Citrate
    Induction drug
    Other Names:
  • Clomid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical pregnancy rate [3 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ain Shams Univerisity Cairo Egypt

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    • Principal Investigator: Asmaa Salih, Resident, AinShams University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Asmaa Abdelbadea Ali Salih, Cairo, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT03566225
    Other Study ID Numbers:
    • AinShamaU
    First Posted:
    Jun 25, 2018
    Last Update Posted:
    Jun 2, 2021
    Last Verified:
    May 1, 2021
    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
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome
    Metformin
    Pioglitazone
    Clomiphene
    Enclomiphene
    Zuclomiphene

    Study Results

    No Results Posted as of Jun 2, 2021