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NCT Number: NCT07773337

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

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.

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Key information

Conditions

Ovarian Reserve Markers Adnexal Diseases Anovulation Anovulatory Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Infertility Ovarian Diseases Ovarian Function Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Diyarbakır, 21090, Turkey (Türkiye)

Location contact

abdullah ACAR, MD

CONTACT

[email protected]

+905349271097

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Ovarian Stromal Elasticity Value

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

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

Secondary outcomes

  1. Serum Anti- Mullerian Hormone (AMH)

    Time frame: At baseline (Day 1)

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

  2. Antral Follicle Count (AFC)

    Time frame: At baseline ultasound examination (Day 1)

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

  3. Ovarian Volume

    Time frame: At baseline ultrasound examination(Day 1)

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

  4. Serum Follicle-Stimulating Hormone

    Time frame: at baseline (day 1)

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

  5. Serum Luteinizing Hormone (LH)

    Time frame: at baseline (day 1)

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

  6. Serum Estradiol (E2) Levels

    Time frame: at baseline (day 1)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Abdullah ACAR, MD

CONTACT

[email protected]

+905349271097

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Official study title

Relationship Between Ovarian Stromal Stiffness Measured by Transvaginal Shear Wave Elastography and Hormonal and Ultrasonographic Ovarian Function Parameters

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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