Polycystic Ovary Syndrome (PCOS) WomenNCT06832735
Health-related Quality of Life of Women with Polycystic Ovary Syndrome At Sohag University Hospital
An observational study of Polycystic Ovary Syndrome (PCOS) Women, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS) Women
- How many people
- 352 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2025to 1 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: women with PCOS visiting Gynecology and clinical nutrition outpatient clinics at Sohag university hospital during the period of 6 months.
Who may be able to join
- • 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
Who cannot join
- • Females below 18 years old.
- Females above 45 years old.
- Patients having major life event or problem also affecting quality of life.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
- Conditions
- Polycystic Ovary Syndrome (PCOS) Women
- Keywords
- PCOS, Quality of life, PCOSQ, BMI
- Medical subject headings
- Polycystic Ovary Syndrome
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 |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 months after answering the polycystic ovary syndrome questionnaire
Secondary outcomes (1)
Factors affecting health related quality of life of women with PCOS
by medical chart developed by the investigator and the supervisors that will include Socio-demographic data of the women with PCOS, medical history and body measurements.
Measured: 2 months after collecting data from the medical chart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study startMar 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS) WomenStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samah Wagdy Abdelaziz, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832735
- Sponsor's protocol ID
- Soh-Med-25-2--3MD
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-related Quality of Life of Women with Polycystic Ovary Syndrome At Sohag University Hospital
- ClinicalTrials.gov ID
- NCT06832735
- Acronym / sponsor ID
- Soh-Med-25-2--3MD
- Conditions
- Polycystic Ovary Syndrome (PCOS) Women
- Keywords
- PCOS, Quality of life, PCOSQ, BMI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 18 Feb 2025 (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.
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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women with PCOS visiting Gynecology and clinical nutrition outpatient clinics at Sohag university hospital during the period of 6 months.
Key inclusion criteria (2 listed)
- • Female cases between 18 and 45.
Key exclusion criteria (3 listed)
- • Females below 18 years old.
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
health related quality of life of women with PCOS
Time frame: 2 months after answering the polycystic ovary syndrome questionnaire
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)
1 secondary outcome
Factors affecting health related quality of life of women with PCOS
Time frame: 2 months after collecting data from the medical chart
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Polycystic Ovary Syndrome (PCOS) Women, run by Sohag 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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 18 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samah Wagdy Elkhayat, Assistant lecturer (+201006300880, samahwagdy@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
health related quality of life of women with PCOS (time frame: 2 months after answering the polycystic ovary syndrome questionnaire). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2025.