ClinicalTrials.gg
CompletedNCT06208995Updated Mar 19, 2026

Quality of Life in Normogonadotropic Anovulation

An observational study in Anovulation and Irregular Menses, sponsored by Jagiellonian University. Completed at 1 site in Poland. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by Jagiellonian University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
990
Ages
18 Years to 45 Years
Sex
Female
01

Study 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). 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.

02

Conditions studied

  • Anovulation
  • Irregular Menses

Keywords

  • anovulation
  • irregular menstruation
  • PCOS
  • HPOD
  • quality of life
03

In context

Anovulation

75 studies on the registry are indexed under Anovulation; 7 are open to participants now.

This study's enrollment of 990 is above the median of 300 across 17 observational studies indexed under Anovulation.

Browse Anovulation studies →

Lead sponsor

Jagiellonian University is the lead sponsor of 161 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study group will consist of women aged 18-45, diagnosed with menstrual disorders and suspected PCOS.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • menstrual cycle length \<21 days or >35 days
  • age 18-45 years

Exclusion criteria

Exclusion Criteria:

  • previous ovarian surgery
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
990 participants (actual)
Patient registry
No

Groups and cohorts

  • Arm 1

    Polycystic Ovary Syndrome (PCOS)

    Other: 36-Item Short Form Survey Instrument (SF-36)

  • Arm 2

    Hypothalamic-Pituitary-Ovarian Axis Dysfunction

    Other: 36-Item Short Form Survey Instrument (SF-36)

Interventions

  • Other36-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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 12 months

  2. 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)

    Time frame: 12 months

  3. 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)

    Time frame: 12 months

  4. 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)

    Time frame: 12 months

  5. 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)

    Time frame: 12 months

  6. 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)

    Time frame: 12 months

  7. 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)

    Time frame: 12 months

  8. 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)

    Time frame: 12 months

07

Study locations

1 site
  • Jagiellonian University Medical College
    Krakow, 31-501, Poland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06208995
Responsible party
Iwona Magdalena Gawron (PhD, MD, Jagiellonian University) — Principal investigator
First posted
Jan 17, 2024
Start date
Jul 1, 2023
Primary completion
Dec 1, 2024
Completion
Dec 30, 2024
Last update
Mar 19, 2026

Study contacts

Robert Jach, Prof., PhD
study chair · Jagiellonian University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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