NCT05010551

Brief Summary

To translate and validate modifies polycystic ovary syndrome quality of life (MPCOQ) questionnaire into Urdu. To evaluate the reliability, validity and of Urdu version of modified polycystic ovary syndrome quality of life questionnaire (MPCOQ).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

November 20, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

August 11, 2021

Last Update Submit

April 21, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Modified polycystic ovary syndrome quality of life questionnaire

    The tool is to measure health related quality of life of females suffering from PCOS. it contains 30 items with 6 main areas related to hirsutism , acne, weight, infertility, emotional disturbance, menstrual difficulties to define different symptoms of PCOS. then quality of life will be measured of respective patients. The total is 210 with higher score indicating a better quality of life.

    6 months

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMarried Diagnosed with PCOS
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with PCOS

You may qualify if:

  • Age 18 - 30
  • Married
  • Female patients diagnosed with PCOS, having 2 of the following Rotterdam diagnostic criteria:
  • I. Polycystic ovaries visualized on ultrasound scan (presence of 12 follicles or more in one or both ovaries and/or increased ovarian volume \>10ml II. Clinical signs of hyperandrogenism (the hirsutism score based on the Ferriman-Gallwey score \>7 or obvious acne) III. Having an interval between menstrual periods \>35 days and/or amenorrhea as the absence of vaginal bleeding for at least 6 months, i.e. 199 days Patients who are willing to participate

You may not qualify if:

  • Non-adrenal hyperplasia, thyroid dysfunction, and hyperprolactinemia
  • Female undergoing Hormone Replacement Therapy
  • Female with malignancies
  • Any recent fractures, surgeries
  • Patient with nephrological and neurological conditions
  • Dementia or cognitive impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Abeer Fatima

Islamabad, Punjab Province, 45000, Pakistan

Location

Zohra Institute of Health Sciences

Rawalpindi, Pakistan

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 Officials

  • Sarah Ehsan

    Riphah International University

    PRINCIPAL INVESTIGATOR
  • Abeer Fatima, MS(cppt)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2021

First Posted

August 18, 2021

Study Start

November 20, 2020

Primary Completion

May 30, 2021

Study Completion

August 30, 2021

Last Updated

April 28, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations