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

August 18, 2026 updated by: Ihsan Bağlı, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
      • Diyarbakır, Turkey (Türkiye), 21090
        • University of Health Sciences Gazi Yaşargil Training and Research Hospital, Department of Obstetrics and Gynaecology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Study Population

Female Patients of Reproductive Age (18-45 years) presenting to the gynecology outpatient clinic for routine gynecological evaluation or ovarian function assessment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Ovarian Function Assessment Group
Female Patients of Reproductive Age
Diagnostic test: Transvaginal Shear Wave Elastography
Measurement of ovarian stromal elasticity using transvaginal shear wave elastography alongside standard ultrasound evaluation of antral follicle count and ovarian volume

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
At the time of baseline ultrasound examination(Day 1)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum Anti- Mullerian Hormone (AMH)
Time Frame: At baseline (Day 1)
Measurement of Serum AMH concentration (ng/mL) to assess baseline ovarian reserve
At baseline (Day 1)
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
At baseline ultasound examination (Day 1)
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
At baseline ultrasound examination(Day 1)
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)
at baseline (day 1)
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)
at baseline (day 1)
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)
at baseline (day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Serap M. ÖZÇELİK OTCU, MD, AssocProf., University of Health Sciences Gazi Yasargil Training and Research Hospital, Dept. of OB/GYN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026/321

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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