Quality of Life in Normogonadotropic Anovulation

NCT06208995 | Completed DMC

• 1 other identifier: 118.6120.21.2023
• Study Type: observational
• Target: 990
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anovulation; Irregular Menses

Keywords

anovulation; irregular menstruation; PCOS; HPOD; quality of life

Outcome Measures

Primary Outcomes (8)

• 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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  12 months

Study Arms (2)

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

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

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• previous ovarian surgery

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University Medical College

Krakow, 31-501, Poland

Location

MeSH Terms

Conditions

Anovulation; Menstruation Disturbances

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Jach, Prof., PhD

  Jagiellonian University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: January 17, 2024
• Study Start: July 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 30, 2024
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)