NCT03157921

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

May 16, 2017

Last Update Submit

May 16, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

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

    3 months

Interventions

assessment of ovarian volume and antral follicle count

Hormonal levelsDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

infertile women with poly-cystic ovary syndrome

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

May 16, 2017

First Posted

May 17, 2017

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

May 17, 2017

Record last verified: 2017-05

Locations