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OpenTrials
Completed

NCT Number: NCT03566225

Pioglitazone Versus Metformin 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

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Key information

Conditions

Pioglitazone

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Ain Shams Univerisity

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pioglitazone

Drug

Insulin sensitizing agents

Other names: Glustazon

metformin

Drug

Insulin sensitizing agent

Other names: Cidophage

Clomiphene Citrate

Drug

Induction drug

Other names: Clomid

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 25, 2018
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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