Uterine and Endometrial Volume in PCOS and HPOD

NCT06211608 — Completed, 648 participants, Jagiellonian University

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

RegistryNCT06211608
StatusCompleted
Study typeObservational
Enrollment648 (Actual)
SponsorJagiellonian University (Other)
ConditionsAnovulation, Irregular Menses
InterventionsTwo-dimensional and three-dimensional ultrasound of the female reproductive organ (Diagnostic test)
Datesstart 2024-01-05, primary completion 2024-12-31, completion 2024-12-31, first posted 2024-01-18, last updated 2026-03-19
Locations1 site in Poland

Related Papers Related Patents Related Grants Related Experts
All trials for Anovulation All trials for Irregular Menses All trials of Two-dimensional and three-dimensional ultrasound of the female reproductive organ

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Arm 1Diagnostic Test: Two-dimensional and three-dimensional ultrasound of the female reproductive organPolycystic ovary syndrome (PCOS)
Arm 2Diagnostic Test: Two-dimensional and three-dimensional ultrasound of the female reproductive organHypothalamic-pituitary-ovarian axis dysfunction (HPOD)
  • 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

+Outcome measures

Primary outcomes

  • Uterine volume [12 months]: Comparison of uterine volume in ml calculated using the presented formula in both arms of the study
  • Endometrium volume [12 months]: Comparison of endometrial volume in ml calculated using the presented formula in both arms of the study

+Eligibility

Sex: Female, ages: 18 Years to 45 Years

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

+Locations (1)

FacilityCityCountryStatus
Jagiellonian University Medical CollegeKrakowPoland

+Investigators