Ovarian Stromal Stiffness and Ovarian Reserve Parameters Via Transvaginal Shear Wave Elastography

N/ANot Yet RecruitingNCT07773337

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital100 enrolled

Overview

This study aims to evaluate the relationship between ovarian stromal stiffness measured by transvaginal shear wave elastography (SWE) and conventional hormonal and ultrasonographic parameters of ovarian reserve. Reproductive-aged female patients will be evaluated to determine whether tissue elasticity provided by SWE correlates with ovarian function markers such as anti-Müllerian hormone (AMH), antral follicle count (AFC), and ovarian volume.

Transvaginal ultrasound combined with shear wave elastography will be performed on all participants. Ovarian stromal stiffness values (measured in kilopascals or meters per second) will be correlated with basal serum hormone levels (AMH, FSH, LH, Estradiol) and ultrasonographic ovarian reserve criteria (antral follicle count and total ovarian volume).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Ovarian Reserve Markers Ovarian Function Infertility Anovulatory

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Female patients aged 18 to 45 years. * Regular menstrual cycles (21-35 days) or irregular menstruel cycles (oligo-anovaltion) * Normal pelvic anatomy on baseline ultrasound evaluation. * Written informed consent to participate in the study. Exclusion Criteria: * History of prior ovarian or adnexal surgery. * History of pelvic radiotherapy or chemotherapy. * Presence of structural pelvic/ovarian pathology (e.g., endometrioma, ovarian cyst, dermoid cyst, active pelvic inflammatory disease). * Use of hormonal contraceptives, ovulation induction agents, or hormone therapy within the last 3 months. * Pregnancy or current lactation. * Severe obesity or technical limitations preventing adequate transvaginal ultrasound and elastography imaging

Outcomes

Primary Outcomes

Ovarian Stromal Elasticity Value

Measurement of ovarian stromal tissue stiffness/elasticity using transvaginal shear wave elastography, expressed in kilopascals (kPa) or velocity (m/s).

Time frame: At the time of baseline ultrasound examination(Day 1)

Secondary Outcomes

Serum Anti- Mullerian Hormone (AMH)

Measurement of Serum AMH concentration (ng/mL) to assess baseline ovarian reserve

Time frame: At baseline (Day 1)

Antral Follicle Count (AFC)

Total number of antral follicles(measuring 2-10 mm) counted in both ovaries via transvaginal ultrasonography

Time frame: At baseline ultasound examination (Day 1)

Ovarian Volume

Measurement of ovarian volume (cm\^3) calculated using the prolate ellipsoid formula (length\*width\*height\*0,523) via transvaginal ultrasonography

Time frame: At baseline ultrasound examination(Day 1)

Serum Follicle-Stimulating Hormone

Measurement of Basal serum FSH concentration (IU/L) evaluated in the early follicular phase (Day 2-4 of menstrual cycle)

Time frame: at baseline (day 1)

Serum Luteinizing Hormone (LH)

Measurement of Basal Serum LH concentration (IU/L) evaluated in the early follicular phase (Day 2-4of menstruel cycle)

Time frame: at baseline (day 1)

Serum Estradiol (E2) Levels

Measurement of basal serum estradiol concentration (pg/ml) evaluated in the early follicular phase (Day 2-4 of menstruel cycle)

Time frame: at baseline (day 1)

Ovarian Stromal Stiffness and Ovarian Reserve Parameters Via Transvaginal Shear Wave Elastography

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts