Not yet taking people in TürkiyeNo phase

Studies Fibromyalgia and Pain in Women With Polycystic Ovary Syndrome

Observes how often fibromyalgia occurs in women with polycystic ovary syndrome, and their pain.

Key facts

Who runs it: Ufuk University
Where: Ankara, TürkiyeSee the site
Trial code: NCT07189247
Registry title: Evaluation of Fibromyalgia Frequency and Pain Parameters in Women With Polycystic Ovary Syndrome
Status: Not yet recruiting
People taking part: 140 people, planned
Started: 1 Nov 2025
Planned end: 1 Nov 2026
Type of study: Observational
Record updated: 23 September 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women aged 18-40 who have been diagnosed with polycystic ovary syndrome (PCOS). It studies how often fibromyalgia, pain, anxiety and low mood occur in these women.

Age: 18 to 40 years
Sex: Women only
Disease stage: Polycystic ovary syndrome (PCOS) diagnosed by a gynecologist according to the Rotterdam criteria.
Earlier treatment: Must not have had pelvic surgery before. Must not have a history of psychiatric medication or substance abuse.

Main reasons for not taking part

Uterine or adnexal problems seen on ultrasound (for example polyps, fibroids, adnexal masses)
Previous pelvic surgery
Other causes of excess hair growth and irregular periods (for example Cushing's syndrome, hypothyroidism)
Pregnancy
History of muscle or rheumatological disease, uncontrolled diabetes, or severe psychiatric illness

The registry criteria, word for word

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Who can take part

Women aged 18-40
Those diagnosed with Polycystic Ovary Syndrome by a Gynecologist and Obstetrician (according to the Rotterdam Criteria)
Those who agreed to participate in the study and signed the informed consent form

Who cannot take part

Patients with previous pelvic surgery
Secondary causes of hirsutism and oligomenorrhea (non-classical congenital adrenal hyperplasia, Cushing's syndrome, hypothyroidism, prolactinoma, androgen-synthesizing tumor)
Patients with a history of muscular or rheumatological diseases
Patients with uncontrolled diabetes
Patients with severe psychiatric illnesses or a history of psychiatric medication/substance abuse
Patients with underlying uterine or adnexal pathologies (endometrial polyps, adenomyosis, uterine fibroids, adnexal masses, etc.) identified by ultrasound
Pregnant women

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 40 years old?

Where in Türkiye

Ufuk UniversityAnkara, TürkiyeContact: Elzem Bolkan GünaydınNo longer taking part

About the trial

What the trial wants to find out

The primary objective was to determine the prevalence of fibromyalgia in women with PCOS and to examine the relationship between fibromyalgia and psychological status (depression and anxiety). Secondary objectives were to explore the potential link between fibromyalgia and insulin resistance, taking into account phenotypic differences. To assess the relationship between fibromyalgia severity and quality of life and pressure pain threshold measurements. To analyze the impact of pain and mood disorders on PCOS phenotypes and to demonstrate the role of insulin resistance in predicting fibromyalgia.

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Participants will be women aged 18-40 diagnosed with PCOS according to the Rotterdam criteria, and a healthy control group of a similar age. When making a PCOS diagnosis, clinical (hirsutism, acne, menstrual irregularity), biochemical (free testosterone, DHEAS, androstenedione, etc.), and ultrasonographic (polycystic ovary morphology) findings will be evaluated. The control group will consist of healthy volunteers presenting with gynecological complaints other than PCOS and without chronic diseases.

Examination and Assessment Process Obstetrics and Gynecology Outpatient Clinic: PCOS diagnosis, demographic data, biochemical tests (glucose, insulin, HOMA-IR, etc.), and phenotyping.

Physical Therapy and Rehabilitation: Application of the 2016 ACR fibromyalgia criteria in a single-blind trial, including measurement of pressure pain threshold (algometer), fibromyalgia severity scale, and recording of Fibromyalgia Impact Questionnaire scores.

Psychological Assessment The HADS (Hospital Anxiety and Depression Scale) will be administered to assess depression and anxiety levels.

Scores obtained will be compared with fibromyalgia diagnosis and PCOS phenotypes to examine the influence of psychological factors on pain perception.