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Prevalence of Pregnancy in Polycystic Ovary Syndrome

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ClinicalTrials.gov Identifier: NCT03157921
Recruitment Status : Completed
First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

Brief Summary:
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.

Condition or disease Intervention/treatment
Polycystic Ovary Syndrome Radiation: transvaginal ultrasound Diagnostic Test: Hormonal levels

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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Prevalence of Spontaneous Ovulation and Pregnancy in Patients With Polycystic Ovary Syndrome
Actual Study Start Date : April 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Radiation: transvaginal ultrasound
    assessment of ovarian volume and antral follicle count
  • Diagnostic Test: Hormonal levels
    follicle stimulating hormone level, luteinizing hormone level and anti-mullerian hormone level


Primary Outcome Measures :
  1. Number of poly-cystic ovarian syndrome women who will be ovulated [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Probability Sample
Study Population
infertile women with poly-cystic ovary syndrome
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

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): NCT03157921


Locations
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Egypt
Women Health Hospital - Assiut university
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University

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Responsible Party: Mohammed Khairy Ali, Lecturer of obstetrics and gynecology, Assiut University
ClinicalTrials.gov Identifier: NCT03157921     History of Changes
Other Study ID Numbers: 17100186
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases