Quality of Life in Normogonadotropic Anovulation

March 17, 2026 updated by: Iwona Magdalena Gawron, Jagiellonian University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

990

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

  • Poland
      • Krakow, Poland, 31-501
        • Jagiellonian University Medical College

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

  • Adult

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • previous ovarian surgery

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
Intervention / Treatment
Arm 1
Polycystic Ovary Syndrome (PCOS)
Other: 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
Arm 2
Hypothalamic-Pituitary-Ovarian Axis Dysfunction
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months
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)
12 months
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)
12 months
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)
12 months
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)
12 months
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)
12 months
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)
12 months
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)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Investigators

  • Study Chair: Robert Jach, Prof., PhD, Jagiellonian University

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)

July 1, 2023

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

January 6, 2024

First Submitted That Met QC Criteria

January 6, 2024

First Posted (Actual)

January 17, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 118.6120.21.2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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