- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03157921
Prevalence of Pregnancy in Polycystic Ovary Syndrome
May 16, 2017 updated by: Mohammed Khairy Ali, Assiut University
Prevalence of Spontaneous Ovulation and Pregnancy in Patients With 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Assiut, Egypt, 71111
- Women Health Hospital - Assiut university
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
infertile women with poly-cystic ovary syndrome
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of poly-cystic ovarian syndrome women who will be ovulated
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2016
Primary Completion (ACTUAL)
April 1, 2017
Study Completion (ACTUAL)
May 1, 2017
Study Registration Dates
First Submitted
May 16, 2017
First Submitted That Met QC Criteria
May 16, 2017
First Posted (ACTUAL)
May 17, 2017
Study Record Updates
Last Update Posted (ACTUAL)
May 17, 2017
Last Update Submitted That Met QC Criteria
May 16, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17100186
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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