Uterine and Endometrial Volume in PCOS and HPOD

NCT ID: NCT06211608

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 650 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-05
• Study Completion Date: 2024-12-31

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.

Detailed Description

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). The exact etiology of both entities is unknown. The diagnosis of PCOS requires meeting the Rotterdam criteria. HPOD, in turn, is considered a functional disorder of the axis, related to lifestyle factors, and the diagnosis is made after excluding identifiable causes of ovulation disorders. 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. The dimensions and volume of the uterus and endometrium may influence the clinical pregnancy rate in women undergoing assisted reproductive technologies. Both too small and too large sizes and volumes of the uterus may reduce the rate of clinical pregnancies. Too small dimensions may result from hypoestrogenism, while excessive size may be the result of estrogen-progesterone imbalance accompanying PCOS, increased uterine vascularity, as well as estrogen-dependent changes in the uterine myometrium, such as adenomyosis. Similarly, too "thin" endometrium and too thick (cystic) endometrium may reduce the receptivity of the endometrium. 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 uterine volume and endometrial volume among women with PCOS and women with HPOD. The volume of the uterus will be determined according to the formula: V = (π/6) × length × width × height (in cm and given in ml). The volume of the endometrium will also be measured according to a similar formula.

Conditions

Anovulation; Irregular Menses

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Arm 1

Polycystic ovary syndrome (PCOS)

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

Intervention Type: 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 2

Hypothalamic-pituitary-ovarian axis dysfunction (HPOD)

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

Intervention Type: 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

Interventions

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

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jagiellonian University

OTHER

Sponsor Role: lead

Responsible Party

Iwona Magdalena Gawron

PhD, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Jach, Prof.

Role: STUDY_CHAIR

Jagiellonian University

Locations

Jagiellonian University Medical College

Krakow, , Poland

Countries

Poland

Other Identifiers

118.6120.53.2023

Identifier Type: -

Identifier Source: org_study_id