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OpenTrials
Completed

NCT Number: NCT02562664

Metformin Improves Clinical Pregnancy Rate in Polycystic Ovarian Syndrome Patients

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

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Key information

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

CC

Drug

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

Placebo tablets

Drug

Placebo tablets taken twice daily continuously for three cycles.

metformin

Drug

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

Primary outcomes

  1. Pregnancy rate

    Time frame: 6 months

Secondary outcomes

  1. Fasting glucose (mg/dl)

    Time frame: 6 months

  2. Fasting insulin (mg/dl)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 29, 2015
Registry last updated
Aug 12, 2020

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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