NCT05056272

Brief Summary

Polycystic ovary syndrome (PCOS) is a common hormonal disorder in females in reproductive age associated with signs and symptoms as amenorrhea or oligomenorrhea, obesity,infertility acne and hirsutism tism that mostly Reduce self steem and having negative impact on physical and sexual quality of life , the management of signs and symptoms should result in improvement in the quality of life

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

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

September 14, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 24, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

9 months

First QC Date

September 14, 2021

Last Update Submit

January 20, 2024

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

  • Prevellance of anxiety and sexual malfunction

    Anticipated

    6 months

Study Arms (2)

PCOS GROUP

Non PCOS group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMarried infertile
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Polycystic ovary syndrome patients and infertile

You may qualify if:

  • \- Age:20-40 Married infertile

You may not qualify if:

  • any other diseases could affect quality of life

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, Egypt

Location

Related Publications (3)

  • Ehrmann DA. Polycystic ovary syndrome. N Engl J Med. 2005 Mar 24;352(12):1223-36. doi: 10.1056/NEJMra041536. No abstract available.

    PMID: 15788499RESULT

  • Hahn S, Janssen OE, Tan S, Pleger K, Mann K, Schedlowski M, Kimmig R, Benson S, Balamitsa E, Elsenbruch S. Clinical and psychological correlates of quality-of-life in polycystic ovary syndrome. Eur J Endocrinol. 2005 Dec;153(6):853-60. doi: 10.1530/eje.1.02024.

    PMID: 16322391RESULT

  • Akbari Sene A, Tahmasbi B, Keypour F, Zamanian H, Golbabaei F, Amini-Tehrani M. Differences in and Correlates of Sexual Function in Infertile Women with and without Polycystic Ovary Syndrome. Int J Fertil Steril. 2021 Jan;15(1):65-72. doi: 10.22074/ijfs.2021.6206. Epub 2021 Jan 19.

    PMID: 33497050RESULT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 14, 2021

First Posted

September 24, 2021

Study Start

January 1, 2022

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Application of female sexual function index and beck anxiety inventory for prevellance of these problems

Shared Documents
STUDY PROTOCOL
Time Frame
Anticipated to be collected within 1year
Access Criteria
Married infertile women with polycystic ovary syndrome signs and symptoms

Locations

EG(1)