Quality of Life in Normogonadotropic Anovulation

J

Jagiellonian University

Status

Enrolling

Conditions

Irregular Menses
Anovulation

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT06208995
118.6120.21.2023

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • previous ovarian surgery

Trial design

300 participants in 2 patient groups

Arm 1
Description:
Polycystic Ovary Syndrome (PCOS)
Treatment:
Other: 36-Item Short Form Survey Instrument (SF-36)
Arm 2
Description:
Hypothalamic-Pituitary-Ovarian Axis Dysfunction
Treatment:
Other: 36-Item Short Form Survey Instrument (SF-36)

Trial contacts and locations

1

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Central trial contact

Iwona Gawron, PhD, MD

Data sourced from clinicaltrials.gov

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