Uterine and Endometrial Volume in PCOS and HPOD

NCT06211608 | Completed DMC

• 1 other identifier: 118.6120.53.2023
• Study Type: observational
• Target: 648
• Locations: 1 country
• Sites: 1

Brief Summary

Group II causes of anovulation according to the World Health Organization include polycystic ovary syndrome (PCOS) and the less common dysfunction of the hypothalamic-pituitary-ovarian axis (HPOD). Assessment of ovarian volume, number and morphology of ovarian follicles is essential in the diagnosis of menstrual disorders, including PCOS and HPOD. However, the uterus is a target organ for steroid hormones, and the assessment of uterine size and endometrial morphology may also be of clinical importance. While ultrasonographic features of the ovaries in PCOS have been described and constitute one of the diagnostic criteria for the syndrome (Rotterdam criteria), there is little data on uterine volume in women with PCOS and HPOD. The aim is to compare ultrasound i) uterine volume and ii) endometrial volume among women with PCOS and women with HPOD.

Conditions

Anovulation; Irregular Menses

Keywords

Uterine morphology; PCOS; Hypothalamic-pituitary-ovarian axis dysfunction; Endometrial volume

Outcome Measures

Primary Outcomes (2)

• Uterine volume

  Comparison of uterine volume in ml calculated using the presented formula in both arms of the study

  12 months

• Endometrium volume

  Comparison of endometrial volume in ml calculated using the presented formula in both arms of the study

  12 months

Study Arms (2)

Arm 1

Polycystic ovary syndrome (PCOS)

Diagnostic Test: Two-dimensional and three-dimensional ultrasound of the female reproductive organ

Arm 2

Hypothalamic-pituitary-ovarian axis dysfunction (HPOD)

Diagnostic Test: Two-dimensional and three-dimensional ultrasound of the female reproductive organ

Interventions

Two-dimensional and three-dimensional ultrasound of the female reproductive organ DIAGNOSTIC_TEST

Two-dimensional and three-dimensional ultrasound of the female reproductive organ using a Samsung WS80A or Samsung HERA W10 ultrasound device with a transvaginal or transabdominal transducer

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 will include women diagnosed in the Clinical Department of Gynecological Endocrinology and Gynecology of the University Hospital inn Krakow, Poland, and the Gynecological Endocrinology Clinic due to menstrual disorders or infertility due to ovulation disorders.

You may qualify if:

• age 18-45 years
• no previous diagnosis and treatment due to menstrual disorders or infertility

You may not qualify if:

• previous ovarian surgery
• use of drugs that disturb the functions of the hypothalamic-pituitary-ovarian axis
• uterine tumors

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.

  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 7, 2024
• First Posted: January 18, 2024
• Study Start: January 5, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)