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Completed

NCT Number: NCT03157921

Prevalence of Pregnancy in Polycystic Ovary Syndrome

Polycystic ovary syndrome is the most common endocrine disorder in women of reproductive age, with a prevalence of approximately 5-10%. Polycystic ovary syndrome is diagnosed according to Rotterdam criteria by at least two of the following three key features: oligomenorrhea or amenorrhea; clinical and/or biochemical signs of hyperandrogenism; the presence of polycystic ovaries on ultrasound and exclusion of other endocrine disorders including hyperprolactinemia, thyroid dysfunction and congenital adrenal hyperplasia. Polycystic ovary syndrome is also associated with insulin resistance, obesity and disorders of lipid metabolism, as well as infertility, although these findings have not been addressed in the Rotterdam criteria. Polycystic ovary syndrome is the major cause of anovulatory infertility. The recent studies suggest that anovulation resulting from ovarian follicle abnormalities in Polycystic ovary syndrome patients are 2-fold of normal ovaries. Firstly, early follicular growth is excessive, thus women with Polycystic ovary syndrome are characterized by an excessive number of small antral follicles (2- to 3-fold of normal ovaries). Secondly, the selection of one follicle from the increased pool of selectable follicles and its further maturation to a dominant follicle does not occur. This second abnormality in the folliculogenesis can cause menstrual dysfunction presented as oligomenorrhea or amenorrhea. Historically, Polycystic ovary syndrome treatment has not been curative in nature, instead treatments focus on resolution of clinical manifestations of the disease.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Who can participate

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

Inclusion criteria

  • infertile women
  • age from 18 to 40 years
  • poly-cystic ovary syndrome
  • Body mass index 18.5-35 kg/m2

Exclusion criteria

  • Endocrine disorders (cushing syndrome-congenital adrenal hyperplasia)
  • Systemic disease
  • Use of oral contraceptive,glucocorticoid and antiandrogen
  • Use of ovulation induction or dopaminergic agents
  • Use of antidiabetes, anti obesity drugs
  • history of tubal or ovarian surgery

Treatment and study plan

Transvaginal ultrasound

Radiation

assessment of ovarian volume and antral follicle count

Hormonal levels

Diagnostic Test

follicle stimulating hormone level, luteinizing hormone level and anti-mullerian hormone level

Primary outcomes

  1. Number of poly-cystic ovarian syndrome women who will be ovulated

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Prevalence of Spontaneous Ovulation and Pregnancy in Patients With Polycystic Ovary Syndrome

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 17, 2017
Registry last updated
May 17, 2017

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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