AnovulationNCT06208995
Quality of Life in Normogonadotropic Anovulation
An observational study of Anovulation and Irregular Menses, run by Jagiellonian University at 1 site in Poland.
Trial summary
Among the causes of ovulation disorders (group II of anovulation according to the World Health Organization classification), the dominant one is polycystic ovary syndrome (PCOS), and the remaining cases are classified as Hypothalamic-Pituitary-Ovarian Axis Dysfunction (HPOD). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anovulation, Irregular Menses
- What is being tested?
- 36-Item Short Form Survey Instrument (SF-36)
- How many people
- 990 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2023to 30 Dec 2024
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: The study group will consist of women aged 18-45, diagnosed with menstrual disorders and suspected PCOS.
Who may be able to join
- menstrual cycle length <21 days or >35 days
- age 18-45 years
Who cannot join
- previous ovarian surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Quality of Life in Women With Normogonadotropic Anovulation
Among the causes of ovulation disorders (group II of anovulation according to the World Health Organization classification), the dominant one is polycystic ovary syndrome (PCOS), and the remaining cases are classified as Hypothalamic-Pituitary-Ovarian Axis Dysfunction (HPOD). The exact etiology of both entities is unknown. To diagnose PCOS, the Rotterdam criteria must be met and other conditions that may cause hyperandrogenism or ovulation disorders must be excluded. PCOS is more often accompanied by other endocrine and metabolic disorders, such as obesity, dyslipidemia, hyperandrogenism, insulin resistance, diabetes, hyperprolactinemia and thyroid diseases, as well as infertility due to ovulation defect. These conditions not only significantly reduce quality of life (QoL), but also lead to an increased risk of cardiovascular disease, metabolic syndrome, adverse obstetric outcomes and an increased risk of endometrial cancer, further impairing QoL.
Read the detailed description
A prospective questionnaire study will be conducted regarding the quality of life among women undergoing hormonal diagnostics due to anovulation. The study will include women aged 18-45 with ovulation disorders: PCOS (arm 1) and HPOD (arm 2). The quality of life will be assessed using the self-assessment method using the SF-36 questionnaire (Short Form Health Survey). The questionnaire is intended for a subjective assessment of health status. It consists of 11 questions containing 36 statements that allow you to determine eight quality of life indicators, i.e.: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health, health change.
The percentage score on a scale of 0-100% in each of the 8 life domains will be compared between both arms of the study.
- Conditions
- Anovulation, Irregular Menses
- Being tested
- 36-Item Short Form Survey Instrument (SF-36)
- Keywords
- anovulation, irregular menstruation, PCOS, HPOD, quality of life
- Medical subject headings
- Anovulation, Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
36-Item Short Form Survey Instrument (SF-36)Other
Answering 36 questions in a quality-of-life survey (RAND 36-Item Health Survey 1.0): https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form/survey-instrument.html
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Polycystic Ovary Syndrome (PCOS) Receives: Other: 36-Item Short Form Survey Instrument (SF-36) | |
| Arm 2 | Hypothalamic-Pituitary-Ovarian Axis Dysfunction Receives: Other: 36-Item Short Form Survey Instrument (SF-36) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical functioning
Comparison of physical functioning percentage score between both study arms on a scale from 0 to 100%, where 0% is the lowest result (the worst quality of life) and 100% is the maximum result (the best quality of life)
Measured: 12 months
Bodily pain
Comparison of bodily pain percentage score between both study arms on a scale from 0 to 100%, where 0% is the lowest result (the worst quality of life) and 100% is the maximum result (the best quality of life)
Measured: 12 months
Role limitations due to physical health problems
Comparison of role limitations due to physical health problems percentage score between both study arms on a scale from 0 to 100%, where 0% is the lowest result (the worst quality of life) and 100% is the maximum result (the best quality of life)
Measured: 12 months
Role limitations due to personal or emotional problems
Comparison of role limitations due to personal or emotional problems score between both study arms on a scale from 0 to 100%, where 0% is the lowest result (the worst quality of life) and 100% is the maximum result (the best quality of life)
Measured: 12 months
Emotional well-being
Comparison of emotional well-being percentage score between both study arms on a scale from 0 to 100%, where 0% is the lowest result (the worst quality of life) and 100% is the maximum result (the best quality of life)
Measured: 12 months
Social functioning
Comparison of social functioning percentage score between both study arms on a scale from 0 to 100%, where 0% is the lowest result (the worst quality of life) and 100% is the maximum result (the best quality of life)
Measured: 12 months
Energy/fatigue
Comparison of energy/fatigue percentage score between both study arms on a scale from 0 to 100%, where 0% is the lowest result (the worst quality of life) and 100% is the maximum result (the best quality of life)
Measured: 12 months
General health perceptions
Comparison of general health perceptions percentage score between both study arms on a scale from 0 to 100%, where 0% is the lowest result (the worst quality of life) and 100% is the maximum result (the best quality of life)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Jul 2023
- Primary completion1 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnovulationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 990 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iwona Magdalena Gawron, Jagiellonian University
- Investigators
- Robert Jach, Prof., PhD, Study chair, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208995
- Sponsor's protocol ID
- 118.6120.21.2023
- Status last verified
- Mar 2026
- First submitted
- 6 Jan 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Quality of Life in Women With Normogonadotropic Anovulation
- ClinicalTrials.gov ID
- NCT06208995
- Acronym / sponsor ID
- 118.6120.21.2023
- Conditions
- Anovulation, Irregular Menses
- Keywords
- anovulation, irregular menstruation, PCOS, HPOD, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 990 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 17 Jan 2024 (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.
Among the causes of ovulation disorders (group II of anovulation according to the World Health Organization classification), the dominant one is polycystic ovary syndrome (PCOS), and the remaining cases are classified as Hypothalamic-Pituitary-Ovarian Axis Dysfunction (HPOD). The exact etiology of both entities is unknown. To diagnose PCOS, the Rotterdam criteria must be met and other conditions that may cause hyperandrogenism or ovulation disorders must be excluded. PCOS is more often accompanied by other endocrine and metabolic disorders, such as obesity, dyslipidemia, hyperandrogenism, insulin resistance, diabetes, hyperprolactinemia and thyroid diseases, as well as infertility due to ovulation defect. These conditions not only significantly reduce quality of life (QoL), but also lead to an increased risk of cardiovascular disease, metabolic syndrome, adverse obstetric outcomes and an increased risk of endometrial cancer, further impairing QoL.
Detailed description
A prospective questionnaire study will be conducted regarding the quality of life among women undergoing hormonal diagnostics due to anovulation. The study will include women aged 18-45 with ovulation disorders: PCOS (arm 1) and HPOD (arm 2). The quality of life will be assessed using the self-assessment method using the SF-36 questionnaire (Short Form Health Survey). The questionnaire is intended for a subjective assessment of health status. It consists of 11 questions containing 36 statements that allow you to determine eight quality of life indicators, i.e.: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health, health change.
The percentage score on a scale of 0-100% in each of the 8 life domains will be compared between both arms of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Other: 36-Item Short Form Survey Instrument (SF-36)Polycystic Ovary Syndrome (PCOS) |
| Arm 2 | – | Other: 36-Item Short Form Survey Instrument (SF-36)Hypothalamic-Pituitary-Ovarian Axis Dysfunction |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study group will consist of women aged 18-45, diagnosed with menstrual disorders and suspected PCOS.
Key inclusion criteria (2 listed)
- menstrual cycle length <21 days or >35 days
- age 18-45 years
Key exclusion criteria (1 listed)
- previous ovarian surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 36-Item Short Form Survey Instrument (SF-36)Answering 36 questions in a quality-of-life survey (RAND 36-Item Health Survey 1.0): https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form/survey-instrument.html | Other | Arm 1, Arm 2 |
Primary outcome
Physical functioning
Time frame: 12 months
Comparison of physical functioning percentage score between both study arms on a scale from 0 to 100%, where 0% is the lowest result (the worst quality of life) and 100% is the maximum result (the best quality of life)
Bodily pain
Time frame: 12 months
Comparison of bodily pain percentage score between both study arms on a scale from 0 to 100%, where 0% is the lowest result (the worst quality of life) and 100% is the maximum result (the best quality of life)
Role limitations due to physical health problems
Time frame: 12 months
Comparison of role limitations due to physical health problems percentage score between both study arms on a scale from 0 to 100%, where 0% is the lowest result (the worst quality of life) and 100% is the maximum result (the best quality of life)
Role limitations due to personal or emotional problems
Time frame: 12 months
Comparison of role limitations due to personal or emotional problems score between both study arms on a scale from 0 to 100%, where 0% is the lowest result (the worst quality of life) and 100% is the maximum result (the best quality of life)
Emotional well-being
Time frame: 12 months
Comparison of emotional well-being percentage score between both study arms on a scale from 0 to 100%, where 0% is the lowest result (the worst quality of life) and 100% is the maximum result (the best quality of life)
Social functioning
Time frame: 12 months
Comparison of social functioning percentage score between both study arms on a scale from 0 to 100%, where 0% is the lowest result (the worst quality of life) and 100% is the maximum result (the best quality of life)
Energy/fatigue
Time frame: 12 months
Comparison of energy/fatigue percentage score between both study arms on a scale from 0 to 100%, where 0% is the lowest result (the worst quality of life) and 100% is the maximum result (the best quality of life)
General health perceptions
Time frame: 12 months
Comparison of general health perceptions percentage score between both study arms on a scale from 0 to 100%, where 0% is the lowest result (the worst quality of life) and 100% is the maximum result (the best quality of life)
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 19 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Robert Jach, Prof., PhD study chair
Jagiellonian University
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 Anovulation and Irregular Menses, run by Jagiellonian University at 1 site in Poland.
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 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 19 Mar 2026. 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 Poland. 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?
Physical functioning (time frame: 12 months). The study lists 8 primary outcomes in all. 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 19 Mar 2026.