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Metformin Improves Clinical Pregnancy Rate in Polycystic Ovarian Syndrome Patients

Primary Purpose

Reproductive Endocrinology, Polycystic Ovarian Syndrome

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Placebo tablets

Metformin

About this trial

This is an interventional treatment trial for Reproductive Endocrinology

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

All patients with PCOS fulfilled at least 2 out of the three criteria of Rotterdam consensus 2003

Exclusion Criteria:

liver disease
heart or respiratory failure
alcohol abuse
kidney disease

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

CC with placebo

CC plus Metformin

Arm Description

100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle with placebo tablets taken twice daily continuously for three cycles.

received t100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle with plus Metformin 500 mg twice daily continuously for three cycles.

Outcomes

Primary Outcome Measures

Pregnancy rate

Secondary Outcome Measures

Fasting glucose (mg/dl)

Fasting insulin (mg/dl)

Full Information

NCT ID

NCT02562664

First Posted

September 28, 2015

Last Updated

August 10, 2020

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT02562664

Brief Title

Metformin Improves Clinical Pregnancy Rate in Polycystic Ovarian Syndrome Patients

Official Title

Insulin Sensitizing Agent (Metformin) Improves Clinical Pregnancy Rate and Insulin Parameters in Polycystic Ovarian Syndrome Patients With Acanthosis Nigricans

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Polycystic ovary syndrome (PCOS) is the most common Female endocrine disorder , with a prevalence ranging between 6% to10% based on the National Institutes of Health (NIH) criteria and when the broader Rotterdam criteria are applied it reaches as high as 15%. Typically, PCOS can identify during the early adolescence. Insulin resistance is a common finding in the obese women with PCOS. It is most prevalent and severe in PCOS phenotype involving hyperandrogenism and chronic anovulation. Women with PCOS who have regular cycles are metabolically less abnormal. Acanthosis nigricans (AN) is a dermatosis characterized by velvety, papillomatous, brownish-black, hyperkeratotic plaques, typically of the intertriginous surfaces and neck. Although AN is associated with malignancy, the recognition of its more common connection to obesity and insulin resistance allows for diagnosis of related disorders including type 2 diabetes, the metabolic syndrome, and polycystic ovary syndrome. Significant improvements in ovulation and pregnancy rates as a result of clomiphene treatment after metformin in women with clomiphene-resistant PCOS were reported in a popular randomized, double-blind, placebo-controlled trial . The first pharmacological approach to induction of ovulation in women with PCOS is clomiphene citrate

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Reproductive Endocrinology, Polycystic Ovarian Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CC with placebo

Arm Type

Active Comparator

Arm Description

100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle with placebo tablets taken twice daily continuously for three cycles.

Arm Title

CC plus Metformin

Arm Type

Active Comparator

Arm Description

received t100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle with plus Metformin 500 mg twice daily continuously for three cycles.

Intervention Type

Drug

Intervention Name(s)

Intervention Description

100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle

Intervention Type

Drug

Intervention Name(s)

Placebo tablets

Intervention Description

Placebo tablets taken twice daily continuously for three cycles.

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

wMetformin (Cidophage , Amon , Egypt) 500 mg twice daily continuously for three cycles.

Primary Outcome Measure Information:

Title

Pregnancy rate

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Fasting glucose (mg/dl)

Time Frame

6 months

Title

Fasting insulin (mg/dl)

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All patients with PCOS fulfilled at least 2 out of the three criteria of Rotterdam consensus 2003 Exclusion Criteria: liver disease heart or respiratory failure alcohol abuse kidney disease

12. IPD Sharing Statement

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Metformin Improves Clinical Pregnancy Rate in Polycystic Ovarian Syndrome Patients

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