NCT03436108

Brief Summary

Polycystic ovary syndrome (PCOS) is the most common and the most heterogeneous endocrine disorder in premenopausal women. Its prevalence is estimated from 5 to 10% depending on the diagnosis' criteria . Apart from signs of hyperandrogenism such as acne, hirsutism and hair loss; women with PCOS usually present with menstrual irregularities and fertility problems ..

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
12 months until next milestone

Study Start

First participant enrolled

February 10, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
Last Updated

January 14, 2022

Status Verified

January 1, 2022

Enrollment Period

10 months

First QC Date

February 11, 2018

Last Update Submit

January 2, 2022

Conditions

PCOS

Outcome Measures

Primary Outcomes (1)

  • the number of participants who will have high level of bisphenol in btheir blood

    within 6 weeks

Study Arms (2)

PCOS group

patients who have PCOS

Diagnostic Test: Measurement of Bisphenol in urine

control group

patients who donnot have PCOS

Diagnostic Test: Measurement of Bisphenol in urine

Interventions

Measurement of Bisphenol in urineDIAGNOSTIC_TEST

to see level of this material in blood of women

PCOS groupcontrol group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales with PCOS
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

females who were diagnosed to have PCOS

You may qualify if:

  • Age group: 18-40
  • Females
  • Diagnosed a case of polycystic ovary syndrome

You may not qualify if:

  • Female patients with other acute or chronic illness
  • Cardiovascular disease
  • Neoplasms
  • Current smoking, diabetes mellitus,
  • Renal impairment (serum creatinine 120 mol/liter), and hypertension (blood pressure 140/85 mm Hg).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Algazeerah

Giza, Egypt

Location

MeSH Terms

Interventions

Urination

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Mahmoud Alalfy

    Algazeerah hospital -Location (Giza -Egypt )

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital

Study Record Dates

First Submitted

February 11, 2018

First Posted

February 19, 2018

Study Start

February 10, 2019

Primary Completion

December 1, 2019

Study Completion

January 20, 2020

Last Updated

January 14, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Results will be shared after finishing the research

Locations

EG(1)