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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03566225
Recruitment Status : Active, not recruiting
First Posted : June 25, 2018
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Asmaa Abdelbadea Ali Salih, Ain Shams University

Tracking Information
First Submitted Date  ICMJE May 26, 2018
First Posted Date  ICMJE June 25, 2018
Last Update Posted Date February 18, 2019
Actual Study Start Date  ICMJE January 30, 2018
Estimated Primary Completion Date April 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2018)
Clinical pregnancy rate [ Time Frame: 3 months ]
Pregnancy rate diagnosed by U/S at five weeks after missed menses
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pioglitazone Versus Metformin as First Treatment in Infertile Women With Polycystic Ovary Syndrome
Official Title  ICMJE Combined Pioglitazone and Clomophene Citrate Versus Combined Metformin and Clomiphene Citrate as First Treatment in Infertile Women With Polycystic Ovary Syndrome
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Pioglitazone
Intervention  ICMJE
  • Drug: Pioglitazone
    Insulin sensitizing agents
    Other Name: Glustazon
  • Drug: Metformin
    Insulin sensitizing agent
    Other Name: Cidophage
  • Drug: Clomiphene Citrate
    Induction drug
    Other Name: Clomid
Study Arms  ICMJE
  • Active Comparator: Group A
    Pioglitazone in adose 30 mg tablet will be administered dialy+ clomiphene citrate as ovulation induction
    Interventions:
    • Drug: Pioglitazone
    • Drug: Clomiphene Citrate
  • Placebo Comparator: Group B
    Metformin in adose 1500 mg dialy will be administered + clomiphene citrate
    Interventions:
    • Drug: Metformin
    • Drug: Clomiphene Citrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 20, 2018)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 25, 2019
Estimated Primary Completion Date April 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03566225
Other Study ID Numbers  ICMJE AinShamaU
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Asmaa Abdelbadea Ali Salih, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Asmaa Salih, Resident AinShams University
PRS Account Ain Shams University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP