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NCT Number: NCT06208995

Quality of Life in 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.

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Key information

Conditions

Anovulation Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Irregular Menses Menstruation Disturbances Ovarian Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Jagiellonian University Medical College

Krakow, 31-501, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • previous ovarian surgery

Treatment and study plan

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

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

Assessment of Quality of Life in Women With Normogonadotropic Anovulation

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 17, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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