- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05056272
Anxiety and Sexual Malfunction Functions in Infertile Pcos Women
January 20, 2024 updated by: Ahmed Mohamed Abbas, Assiut University
Anxiety and Sexual Malfunction in Infertile Polycystic Ovarian Syndrome Patients
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
Study Overview
Status
Completed
Conditions
Detailed Description
PCOS is also one of the leading causes of infertility, and infertility has been reported as an important source of stress.
Infertility and subfertility in women with PCOS cause a decrease in women's quality of life and a positive perception of their bodies.
Several studies have reported that female infertility has adverse effects on sexual satisfaction, and it is believed that fertility and anxiety in PCOS affects sexual functions, independent of other components of the disease.
In addition, women with PCOS are more concerned about fertility than their healthy peers, and this concern may affect their overall quality of life.In light of these studies, infertility may have a negative effect on anxiety and also sexual function.Sexual functions and satisfaction have important implications on the overall state of well-being, and a decrease in the quality of sexual life negatively affects participation in social life, Besides it, PCOS causes problems in terms of sexual dysfunction .further
studies are needed to clarify the effects of PCOS on sexual function in Infertile women .
Study Type
Observational
Enrollment (Actual)
129
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Assiut, Egypt
- Faculty of medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Polycystic ovary syndrome patients and infertile
Description
Inclusion Criteria:
- Age:20-40 Married infertile
Exclusion Criteria:
- any other diseases could affect quality of life
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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PCOS GROUP
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Non PCOS group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prevellance of anxiety and sexual malfunction
Time Frame: 6 months
|
Anticipated
|
6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ehrmann DA. Polycystic ovary syndrome. N Engl J Med. 2005 Mar 24;352(12):1223-36. doi: 10.1056/NEJMra041536. No abstract available.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Actual)
October 1, 2022
Study Completion (Actual)
November 1, 2022
Study Registration Dates
First Submitted
September 14, 2021
First Submitted That Met QC Criteria
September 15, 2021
First Posted (Actual)
September 24, 2021
Study Record Updates
Last Update Posted (Actual)
January 23, 2024
Last Update Submitted That Met QC Criteria
January 20, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- ASMPCOSP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Application of female sexual function index and beck anxiety inventory for prevellance of these problems
IPD Sharing Time Frame
Anticipated to be collected within 1year
IPD Sharing Access Criteria
Married infertile women with polycystic ovary syndrome signs and symptoms
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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