Ovarian Reserve MarkersNCT07773337
Ovarian Stromal Stiffness and Ovarian Reserve Parameters Via Transvaginal Shear Wave Elastography
A study testing Transvaginal Shear Wave Elastography in people with Ovarian Reserve Markers and Ovarian Function, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Reserve Markers, Ovarian Function, Infertility
- What is being tested?
- Transvaginal Shear Wave Elastography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
University of Health Sciences Gazi Yaşargil Training and Research Hospital, Department of Obstetrics and Gynaecology
Diyarbakır, 21090
abdullah ACAR, MD, +905349271097, acarabdullah764@gmail.com
About this study
Official title: 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.
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).
- Conditions
- Ovarian Reserve Markers, Ovarian Function, Infertility, Anovulatory
- Being tested
- Transvaginal Shear Wave Elastography
- Keywords
- Shear Wave Elastography, Transvaginal Ultrasound, Ovarian Stroma, Anti-Mullerian Hormone
- Medical subject headings
- Infertility, Anovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal Shear Wave ElastographyDiagnostic test
Measurement of ovarian stromal elasticity using transvaginal shear wave elastography alongside standard ultrasound evaluation of antral follicle count and ovarian volume
| Study group | Role | What they receive |
|---|---|---|
| Ovarian Function Assessment Group | Other | Female Patients of Reproductive Age Receives: Diagnostic Test: Transvaginal Shear Wave Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian Stromal Elasticity Value
Measurement of ovarian stromal tissue stiffness/elasticity using transvaginal shear wave elastography, expressed in kilopascals (kPa) or velocity (m/s).
Measured: At the time of baseline ultrasound examination(Day 1)
Secondary outcomes (6)
Serum Anti- Mullerian Hormone (AMH)
Measurement of Serum AMH concentration (ng/mL) to assess baseline ovarian reserve
Measured: At baseline (Day 1)
Antral Follicle Count (AFC)
Total number of antral follicles(measuring 2-10 mm) counted in both ovaries via transvaginal ultrasonography
Measured: At baseline ultasound examination (Day 1)
Ovarian Volume
Measurement of ovarian volume (cm^3) calculated using the prolate ellipsoid formula (length*width*height*0,523) via transvaginal ultrasonography
Measured: At baseline ultrasound examination(Day 1)
Serum Follicle-Stimulating Hormone
Measurement of Basal serum FSH concentration (IU/L) evaluated in the early follicular phase (Day 2-4 of menstrual cycle)
Measured: at baseline (day 1)
Serum Luteinizing Hormone (LH)
Measurement of Basal Serum LH concentration (IU/L) evaluated in the early follicular phase (Day 2-4of menstruel cycle)
Measured: at baseline (day 1)
Serum Estradiol (E2) Levels
Measurement of basal serum estradiol concentration (pg/ml) evaluated in the early follicular phase (Day 2-4 of menstruel cycle)
Measured: at baseline (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study startAug 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ovarian Reserve MarkersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ihsan Bağlı, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Investigators
- Serap M. ÖZÇELİK OTCU, MD, AssocProf., Principal investigator, University of Health Sciences Gazi Yasargil Training and Research Hospital, Dept. of OB/GYN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773337
- Sponsor's protocol ID
- 2026/321
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 40810622Mumusoglu 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 41067165Zaniker 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 38609185Yildirim 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Ovarian Stromal Stiffness Measured by Transvaginal Shear Wave Elastography and Hormonal and Ultrasonographic Ovarian Function Parameters
- ClinicalTrials.gov ID
- NCT07773337
- Acronym / sponsor ID
- 2026/321
- Conditions
- Ovarian Reserve Markers, Ovarian Function, Infertility, Anovulatory
- Keywords
- Shear Wave Elastography, Transvaginal Ultrasound, Ovarian Stroma, Anti-Mullerian Hormone
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian Function Assessment Group | Other | Diagnostic Test: Transvaginal Shear Wave ElastographyFemale Patients of Reproductive Age |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transvaginal Shear Wave ElastographyMeasurement of ovarian stromal elasticity using transvaginal shear wave elastography alongside standard ultrasound evaluation of antral follicle count and ovarian volume | Diagnostic test | Ovarian Function Assessment Group |
Primary outcome
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).
6 secondary outcomes
Serum Anti- Mullerian Hormone (AMH)
Time frame: At baseline (Day 1)
Antral Follicle Count (AFC)
Time frame: At baseline ultasound examination (Day 1)
Ovarian Volume
Time frame: At baseline ultrasound examination(Day 1)
Serum Follicle-Stimulating Hormone
Time frame: at baseline (day 1)
Serum Luteinizing Hormone (LH)
Time frame: at baseline (day 1)
Serum Estradiol (E2) Levels
Time frame: at baseline (day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Background: PubMed 40810622Zorlu 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.
- Background: PubMed 41067165Mumusoglu 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.
- Background: PubMed 38609185Zaniker 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.
- Background: PubMed 40455435Yildirim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Serap M. ÖZÇELİK OTCU, MD, AssocProf. principal investigator
University of Health Sciences Gazi Yasargil Training and Research Hospital, Dept. of OB/GYN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transvaginal Shear Wave Elastography in people with Ovarian Reserve Markers and Ovarian Function, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdullah ACAR, MD (+905349271097, acarabdullah764@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian Stromal Elasticity Value (time frame: At the time of baseline ultrasound examination(Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07773337, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.