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

ConditionsOvarian Reserve MarkersOvarian FunctionInfertilityAnovulatory
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorSaglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Ovarian Function Assessment GroupOther 1 intervention

Trial outcomes

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: