Quality of LifeNCT05056272
Anxiety and Sexual Malfunction Functions in Infertile Pcos Women
An observational study of Quality of Life, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Quality of Life
- How many people
- 129 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Adult
Study population: Polycystic ovary syndrome patients and infertile
Who may be able to join
- Age:20-40 Married infertile
Who cannot join
- any other diseases could affect quality of life
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PCOS GROUP | Not described | |
| Non PCOS group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevellance of anxiety and sexual malfunction
Anticipated
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 Jan 2022
- Primary completion1 Oct 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056272
- Sponsor's protocol ID
- ASMPCOSP
- Status last verified
- Jan 2024
- First submitted
- 14 Sep 2021
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Application of female sexual function index and beck anxiety inventory for prevellance of these problems
Publications
Ehrmann DA. Polycystic ovary syndrome. N Engl J Med. 2005 Mar 24;352(12):1223-36. doi: 10.1056/NEJMra041536. No abstract available.
PubMed 15788499Hahn 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.
PubMed 16322391Akbari 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.
PubMed 33497050
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety and Sexual Malfunction in Infertile Polycystic Ovarian Syndrome Patients
- ClinicalTrials.gov ID
- NCT05056272
- Acronym / sponsor ID
- ASMPCOSP
- Conditions
- Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS GROUP | – | – |
| Non PCOS group | – | – |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Polycystic ovary syndrome patients and infertile
Key inclusion criteria (1 listed)
- Age:20-40 Married infertile
Key exclusion criteria (1 listed)
- any other diseases could affect quality of life
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevellance of anxiety and sexual malfunction
Time frame: 6 months
Anticipated
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Results publication: PubMed 15788499Ehrmann DA. Polycystic ovary syndrome. N Engl J Med. 2005 Mar 24;352(12):1223-36. doi: 10.1056/NEJMra041536. No abstract available.
- Results publication: PubMed 16322391Hahn 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.
- Results publication: PubMed 33497050Akbari 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.
- Individual participant dataSharing planned: Yes. Application of female sexual function index and beck anxiety inventory for prevellance of these problems
Related trials for Quality of Life
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevellance of anxiety and sexual malfunction (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05056272, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.