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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

Study Description
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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
Pioglitazone Drug: Pioglitazone Drug: Metformin Drug: Clomiphene Citrate 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
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Study Type : Interventional  (Clinical Trial)
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 : January 30, 2018
Estimated Primary Completion Date : April 25, 2019
Estimated Study Completion Date : May 25, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Glustazon

Drug: Clomiphene Citrate
Induction drug
Other Name: Clomid
Placebo Comparator: Group B
Metformin in adose 1500 mg dialy will be administered + clomiphene citrate
 Drug: Metformin
Insulin sensitizing agent
Other Name: Cidophage

Drug: Clomiphene Citrate
Induction drug
Other Name: Clomid


Outcome Measures
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Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 3 months ]
    Pregnancy rate diagnosed by U/S at five weeks after missed menses


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03566225


Locations
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Egypt
Ain Shams Univerisity
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Asmaa Salih, Resident AinShams University
More Information
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Responsible Party: Asmaa Abdelbadea Ali Salih, Cairo, Ain Shams University
ClinicalTrials.gov Identifier: NCT03566225    
Other Study ID Numbers: AinShamaU
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019

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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:
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Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Pioglitazone
Clomiphene
 Enclomiphene
Zuclomiphene
Hypoglycemic Agents
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators