Uterine and Endometrial Volume in PCOS and HPOD

March 17, 2026 updated by: Iwona Magdalena Gawron, Jagiellonian University

Ultrasound Assessment of Uterine and Endometrium Volume in Women With PCOS and HPOD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

648

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Krakow, Poland, 31-501
        • Jagiellonian University Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arm 1
Polycystic ovary syndrome (PCOS)
Diagnostic test: 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
Arm 2
Hypothalamic-pituitary-ovarian axis dysfunction (HPOD)
Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uterine volume
Time Frame: 12 months
Comparison of uterine volume in ml calculated using the presented formula in both arms of the study
12 months
Endometrium volume
Time Frame: 12 months
Comparison of endometrial volume in ml calculated using the presented formula in both arms of the study
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Investigators

  • Study Chair: Robert Jach, Prof., Jagiellonian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

January 7, 2024

First Submitted That Met QC Criteria

January 7, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 118.6120.53.2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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