ClinicalTrials.gg
Not yet recruitingNCT07773337Updated Aug 20, 2026

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

An interventional study of Transvaginal Shear Wave Elastography in Ovarian Reserve Markers, Ovarian Function and Infertility, sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the detailed description

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).

02

Conditions studied

  • Ovarian Reserve Markers
  • Ovarian Function
  • Infertility
  • Anovulatory

Keywords

  • Shear Wave Elastography
  • Transvaginal Ultrasound
  • Ovarian Stroma
  • Anti-Mullerian Hormone
03

In context

Infertility

2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.

This study's planned enrollment of 100 is below the median of 135 across 1,412 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital is the lead sponsor of 59 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to participate in the study.

Exclusion criteria

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 , 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    Ovarian Function Assessment Group

    Female Patients of Reproductive Age

    Diagnostic Test: Transvaginal Shear Wave Elastography

Interventions

  • Diagnostic testTransvaginal Shear Wave Elastography

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

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What researchers measure

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).

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

Secondary outcomes

  1. Serum Anti- Mullerian Hormone (AMH)

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

    Time frame: At baseline (Day 1)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

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Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 40810622 ↗
  • 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. PubMed 41067165 ↗
  • 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. PubMed 38609185 ↗
  • 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. PubMed 40455435 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07773337
Lead sponsor
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Responsible party
Ihsan Bağlı (Head of Department(Department of Obstetrics and Gynaecology), Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital) — Principal investigator
First posted
Aug 19, 2026
Start date
Aug 2026 (estimated)
Primary completion
Nov 15, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Aug 20, 2026

Study contacts

Abdullah ACAR, MD
Contact
acarabdullah764@gmail.com
+905349271097
Serap M. ÖZÇELİK OTCU, MD, AssocProf.
principal investigator · University of Health Sciences Gazi Yasargil Training and Research Hospital, Dept. of OB/GYN

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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