Pioglitazone Versus Metformin as First Treatment in Infertile Women With Polycystic Ovary Syndrome
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ClinicalTrials.gov Identifier: NCT03566225 |
Recruitment Status :
Completed
First Posted : June 25, 2018
Last Update Posted : June 2, 2021
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pioglitazone | Drug: Pioglitazone Drug: Metformin Drug: Clomiphene Citrate | Early Phase 1 |
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
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 |
Actual Primary Completion Date : | February 28, 2021 |
Actual Study Completion Date : | March 30, 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Group A
Pioglitazone in adose 30 mg tablet will be administered dialy+ clomiphene citrate as ovulation induction
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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
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Drug: Metformin
Insulin sensitizing agent
Other Name: Cidophage Drug: Clomiphene Citrate Induction drug
Other Name: Clomid |
- Clinical pregnancy rate [ Time Frame: 3 months ]Pregnancy rate diagnosed by U/S at five weeks after missed menses

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Ages Eligible for Study: | 20 Years to 35 Years (Adult) |
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.

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
Egypt | |
Ain Shams Univerisity | |
Cairo, Egypt |
Principal Investigator: | Asmaa Salih, Resident | AinShams University |
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: | June 2, 2021 |
Last Verified: | May 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 |
Polycystic Ovary Syndrome Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases 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 |