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

NCT07773337 | Not Yet Recruiting

• 1 other identifier: 2026/321
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Reserve Markers; Ovarian Function; Infertility; Anovulatory

Keywords

Shear Wave Elastography; Transvaginal Ultrasound; Ovarian Stroma; Anti-Mullerian Hormone

Outcome Measures

Primary Outcomes (1)

• Ovarian Stromal Elasticity Value

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

  At the time of baseline ultrasound examination(Day 1)

Secondary Outcomes (6)

• Serum Anti- Mullerian Hormone (AMH)

  At baseline (Day 1)

• Antral Follicle Count (AFC)

  At baseline ultasound examination (Day 1)

• Ovarian Volume

  At baseline ultrasound examination(Day 1)

• Serum Follicle-Stimulating Hormone

  at baseline (day 1)

• Serum Luteinizing Hormone (LH)

  at baseline (day 1)

Study Arms (1)

Ovarian Function Assessment Group

OTHER

Female Patients of Reproductive Age

Diagnostic Test: Transvaginal Shear Wave Elastography

Interventions

Transvaginal Shear Wave Elastography DIAGNOSTIC_TEST

Measurement of ovarian stromal elasticity using transvaginal shear wave elastography alongside standard ultrasound evaluation of antral follicle count and ovarian volume

Ovarian Function Assessment Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences Gazi Yaşargil Training and Research Hospital, Department of Obstetrics and Gynaecology

Diyarbakır, 21090, Turkey (Türkiye)

Location

Related Publications (4)

• Zorlu U, Yilmazer-Zorlu SN, Yalcin HR. Can shear wave elastography be used as a diagnostic marker in polycystic ovary syndrome? Int J Gynaecol Obstet. 2026 Feb;172(2):1202-1210. doi: 10.1002/ijgo.70471. Epub 2025 Aug 14.

  PMID: 40810622 BACKGROUND

• Mumusoglu S, Yang Q, Kawamura K, Chang M C, Liu K, Hsueh AJ. Initial and cyclic recruitment of ovarian follicles: a quarter-century update. Reprod Biomed Online. 2025 Nov;51(5):105108. doi: 10.1016/j.rbmo.2025.105108. Epub 2025 Jun 18.

  PMID: 41067165 BACKGROUND

• Zaniker EJ, Zhang M, Hughes L, La Follette L, Atazhanova T, Trofimchuk A, Babayev E, Duncan FE. Shear wave elastography to assess stiffness of the human ovary and other reproductive tissues across the reproductive lifespan in health and diseasedagger. Biol Reprod. 2024 Jun 12;110(6):1100-1114. doi: 10.1093/biolre/ioae050.

  PMID: 38609185 BACKGROUND

• Yildirim M, Duran Kaymak S, Cayonu Kahraman N, Savran Ucok B, Engin-Ustun Y. Assessment of Ovarian Stiffness in Women With Polycystic Ovary Syndrome: A Tertiary Center Shear Wave Elastography Study. J Ultrasound Med. 2025 Oct;44(10):1797-1806. doi: 10.1002/jum.16731. Epub 2025 Jun 2.

  PMID: 40455435 BACKGROUND

MeSH Terms

Conditions

Infertility; Anovulation

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Serap M. ÖZÇELİK OTCU, MD, AssocProf.

  University of Health Sciences Gazi Yasargil Training and Research Hospital, Dept. of OB/GYN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdullah ACAR, MD

CONTACT

+905349271097; acarabdullah764@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department(Department of Obstetrics and Gynaecology)

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 19, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)