Clinical Trials Directory

Trials / Completed

CompletedNCT06211608

Uterine and Endometrial Volume in PCOS and HPOD

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

Status
Completed
Phase
Study type
Observational
Enrollment
648 (actual)
Sponsor
Jagiellonian University · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTTwo-dimensional and three-dimensional ultrasound of the female reproductive organTwo-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

Timeline

Start date
2024-01-05
Primary completion
2024-12-31
Completion
2024-12-31
First posted
2024-01-18
Last updated
2026-03-19

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT06211608. Inclusion in this directory is not an endorsement.