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Metformin Improves Clinical Pregnancy Rate in Polycystic Ovarian Syndrome Patients

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02562664
Enrollment
66
Registered
2015-09-29
Start date
2014-01-31
Completion date
2014-07-31
Last updated
2020-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reproductive Endocrinology, Polycystic Ovarian Syndrome

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

Interventions

DRUGCC

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

DRUGPlacebo tablets

Placebo tablets taken twice daily continuously for three cycles.

DRUGMetformin

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pregnancy rate6 months

Secondary

MeasureTime frame
Fasting glucose (mg/dl)6 months
Fasting insulin (mg/dl)6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026