Clinical trial NCT06208995: Quality of Life in Normogonadotropic Anovulation
Official title: Assessment of Quality of Life in Women With Normogonadotropic Anovulation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anovulation
Irregular Menses
Keywords: anovulation
irregular menstruation
PCOS
HPOD
quality of life
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study group will consist of women aged 18-45, diagnosed with menstrual disorders and suspected PCOS. The size of the study group is estimated at 300 women.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* previous ovarian surgery

Primary outcomes:
measure: Physical functioning
timeFrame: 12 months
measure: Bodily pain
timeFrame: 12 months
measure: Role limitations due to physical health problems
timeFrame: 12 months
measure: Role limitations due to personal or emotional problems
timeFrame: 12 months
measure: Emotional well-being
timeFrame: 12 months
measure: Social functioning
timeFrame: 12 months
measure: Energy/fatigue
timeFrame: 12 months
measure: General health perceptions
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Jagiellonian University Medical College
Study officials:
affiliation: Jagiellonian University
name: Robert Jach, Prof., PhD
role: STUDY_CHAIR
References: