NCT06832735

Brief Summary

It is well-established that PCOS women suffer from anxiety, depression, and markedly reduced QoL ,but There has not yet been a nationally representative study to evaluate the PCOS health related Qol and factors affecting it among women in Egypt. So here we try to cover this gap in this study that will be designed to record the QOL of women with PCOS and factors affecting it. This study aims to assess the health related quality of life of polycystic ovary syndrome and determine factors affecting the HRQOL

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
352

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

February 12, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

February 12, 2025

Last Update Submit

February 12, 2025

Conditions

Keywords

PCOSQuality of lifePCOSQBMI

Outcome Measures

Primary Outcomes (1)

  • health related quality of life of women with PCOS

    The quality of life of the participants will be studied using Polycystic Ovary Syndrome Questionnaire (PCOSQ), which consists of 26 questions and 5 domains ,including emotions (eight questions), body hair (five questions), weight (five questions), infertility (four questions), and menstrual problems (four questions)

    2 months after answering the polycystic ovary syndrome questionnaire

Secondary Outcomes (1)

  • Factors affecting health related quality of life of women with PCOS

    2 months after collecting data from the medical chart

Study Arms (1)

Women with Polycystic ovary syndrome

women with PCOS visiting Gynecology and clinical nutrition outpatient clinics at Sohag university hospital Inclusion criteria: * Female cases between 18 and 45. * Females diagnosed with PCOS per Rotterdam criteria , the most commonly accepted and used for PCOS, a diagnosis is confirmed if any two of the three features (hyperandrogenism, oligomenorrhea or anovulation, and polycystic ovaries) are present in a woman of reproductive age\[7\]. Exclusion criteria: * Females below 18 years old. * Females above 45 years old. * Patients having major life event or problem also affecting quality of life.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

women with PCOS visiting Gynecology and clinical nutrition outpatient clinics at Sohag university hospital during the period of 6 months.

You may qualify if:

  • Female cases between 18 and 45.
  • Females diagnosed with PCOS per Rotterdam criteria , the most commonly accepted and used for PCOS, a diagnosis is confirmed if any two of the three features (hyperandrogenism, oligomenorrhea or anovulation, and polycystic ovaries) are present in a woman of reproductive age

You may not qualify if:

  • Females below 18 years old.
  • Females above 45 years old.
  • Patients having major life event or problem also affecting quality of life.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of medicine Sohag university

Sohag, 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

Central Study Contacts

Samah Wagdy Elkhayat, Assistant lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of family medicine

Study Record Dates

First Submitted

February 12, 2025

First Posted

February 18, 2025

Study Start

March 1, 2025

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

February 18, 2025

Record last verified: 2025-02

Locations