Quality of Life in Normogonadotropic Anovulation

Anovulation Clinical Trial

Official title:

Assessment of Quality of Life in Women With Normogonadotropic Anovulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06208995
• Other study ID #: 118.6120.21.2023
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: Jagiellonian University
• Contact: Iwona Gawron, PhD, MD
• Phone: +48 12 4248551
• Email: iwona.gawron[@]uj.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 30, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• menstrual cycle length <21 days or >35 days

• age 18-45 years

Exclusion Criteria:

• previous ovarian surgery

Related Conditions & MeSH terms

• Anovulation
• Irregular Menses
• Menstruation Disturbances

Intervention

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

Locations

Country	Name	City	State
Poland	Jagiellonian University Medical College	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical functioning	Comparison of physical functioning percentage score between both study arms	12 months
Primary	Bodily pain	Comparison of bodily pain percentage score between both study arms	12 months
Primary	Role limitations due to physical health problems	Comparison of role limitations due to physical health problems percentage score between both study arms	12 months
Primary	Role limitations due to personal or emotional problems	Comparison of role limitations due to personal or emotional problems score between both study arms	12 months
Primary	Emotional well-being	Comparison of emotional well-being percentage score between both study arms	12 months
Primary	Social functioning	Comparison of social functioning percentage score between both study arms	12 months
Primary	Energy/fatigue	Comparison of energy/fatigue percentage score between both study arms	12 months
Primary	General health perceptions	Comparison of general health perceptions percentage score between both study arms	12 months