Prevalence of Pregnancy in Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157921
• Other study ID #: 17100186
• Status: Completed
• Phase: N/A
• First received: May 16, 2017
• Last updated: May 16, 2017
• Start date: April 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Egypt	Women Health Hospital - Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of poly-cystic ovarian syndrome women who will be ovulated		3 months