Infertility (IVF Patients)QUESTNCT06816381
Quantifying Uterine Elastography in Menstruating Women
An observational study of Infertility (IVF Patients) and Infertility Assisted Reproductive Technology, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
Trial summary
This study is aiming to characterize the elasticity of the female reproductive tract including the uterus, cervix and ovary using shear wave elastography at different times during the menstrual cycle and define the standard reference range of normal uterine and ovarian elasticity. 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
- Infertility (IVF Patients), Infertility Assisted Reproductive Technology
- What is being tested?
- Shear wave elastography measurements
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2025to Dec 2027
- Phase
- Observational
- 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
Study population: Nulliparous women with no known infertility, gravid women with no known infertility and primary infertile women without uterine factor infertility
Who may be able to join
- Patients with normal menstrual cycles lasting 28-34 days
- Patients with normal uterine anatomy
- Patients with no prior pregnancy history including miscarriages, terminations, ectopic pregnancies, preterm deliveries, or full-term deliveries
- Patient who have no known infertility (i.e. women who have not tried to conceive)
- Patients with normal menstrual cycles lasting 28 days to 34 days.
- Patients with normal uterine and ovarian anatomy (absence of gross pathology on screening visit ultrasound)
Show all 11Show fewer
- Patients with at least one prior full-term vaginal delivery with time to conception less than one year without the use of assisted reproductive technology.
- Patients with normal menstrual cycles lasting 28 days to 34 days.
- Patients with normal uterine and ovarian anatomy (absence of gross pathology on screening visit ultrasound)
- Patient with no prior pregnancy history including miscarriages, terminations, ectopic pregnancies, preterm deliveries, or full-term deliveries (i.e gravity equals zero).
- Patient with diagnosis of primary infertility, with attempted conception for at least 12 months if younger than 35 years and attempted conception for at least 6 months if 35 years or older.
Who cannot join
- BMI ≥ 35
- Current use of intrauterine devices (IUDs), hormonal implants, or hormonal birth control medications. Participants on hormonal birth control interested in study participation may be included following one month of discontinuation of hormonal medication.
- History of uterine surgery (i.e hysteroscopy, dilation and curettage, myomectomy)
- History of ovarian surgery (i.e ovarian cystectomy, oophorectomy, removal of -endometrioma)
- History of surgically-confirmed or clinically suspected endometriosis or ultrasound evidence of endometriosis (i.e endometrioma)
- Currently present or surgically corrected uterine anomalies
Show all 37Show fewer
- Ultrasound evidence of or history of communicating hydrosalpinx
- Ultrasound evidence of or history of leiomyomas
- Ultrasound evidence of adenomyosis based on the Morphological Uterus Sonographic Assessment criteria (MUSA) (19)
- Ultrasound evidence of ovarian pathology including mature teratoma/dermoid cyst, persistent functional cysts larger than 2 cm, or ovarian cancer.
- Group B
- BMI ≥ 35
- Current use of intrauterine devices (IUDs), hormonal implants, or hormonal birth control medications. Participants on hormonal birth control interested in study participation may be included following one month of discontinuation of hormonal medication.
- History of cesarean section
- Patient who have no known secondary infertility (i.e. women who have not tried to conceive)
- Diagnosis of secondary infertility (i.e women who have attempted pregnancy for 12 months without success)
- History of uterine surgery (i.e hysteroscopy, dilation and curettage, myomectomy)
- History of ovarian surgery (i.e ovarian cystectomy, oophorectomy, removal of endometrioma)
- History of surgically-confirmed or clinically suspected endometriosis or ultrasound evidence of endometriosis (i.e endometrioma)
- Currently present or surgically corrected uterine anomalies
- Ultrasound evidence of or history of communicating hydrosalpinx
- Ultrasound evidence of or history of leiomyomas
- Ultrasound evidence of adenomyosis based on the Morphological Uterus Sonographic Assessment criteria (MUSA) (19)
- Ultrasound evidence of ovarian pathology including mature teratoma/dermoid cyst, persistent functional cysts larger than 2 cm, or ovarian cancer.
- Group C
- BMI ≥ 35
- Current use of intrauterine devices (IUDs), hormonal implants, or hormonal birth control medications. Participants on hormonal birth control interested in study participation may be included following one month of discontinuation of hormonal medication.
- History of three or more failed euploid embryo transfers
- Severe male factor infertility including severe oligozoospermia and cryptozoospermia
- History of uterine surgery (i.e hysteroscopy, dilation and curettage, myomectomy)
- History of ovarian surgery (i.e ovarian cystectomy, oophorectomy, removal of endometrioma)
- History of surgically-confirmed or clinically suspected endometriosis or ultrasound evidence of endometriosis (i.e endometrioma)
- Currently present or surgically corrected uterine anomalies
- Ultrasound evidence of or history of communicating hydrosalpinx
- Ultrasound evidence of or history of leiomyomas
- Ultrasound evidence of adenomyosis based on the Morphological Uterus Sonographic Assessment criteria (MUSA) (19)
- Ultrasound evidence of ovarian pathology including mature teratoma/dermoid cyst, persistent functional cysts larger than 2 cm, or ovarian cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
RMA
Basking Ridge, New Jersey, 07920
Christine Whitehead, MS, BSN, RN, 9736562841, clinicalresearchteam@ivirma.com
About this study
Official title: Characterizing Uterine and Ovarian Tissue Stiffness Via Shear Wave Elastography in Non-Infertile, Fertile, and Infertile Women With Normal Anatomy Across the Menstrual Cycle: A Pilot Study
This study is aiming to characterize the elasticity of the female reproductive tract including the uterus, cervix and ovary using shear wave elastography at different times during the menstrual cycle and define the standard reference range of normal uterine and ovarian elasticity. By doing so, the potential of using shear wave elastography to diagnose and predict outcomes for patients seeking fertility treatment might be established.
- Being tested
- Shear wave elastography measurements
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear wave elastography measurementsDevice
Shear wave elastography measurements in kilopascals via ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Nulliparous Women with No Known infertility | Female patients with normal menstrual cycles, normal ovarian and uterine anatomy and with no known prior pregnancy (including miscarriages, terminations, ectopic pregnancies, preterm and full term deliveries) | |
| Gravid Women with No Known infertility | Female patients with normal menstrual cycles, normal ovarian and uterine anatomy with at least one prior full term vaginal delivery with no known infertility | |
| Primary Infertile Women Without Uterine Factor Infertility | Female patients with normal menstrual cycles, normal ovarian and uterine anatomy and with no known prior pregnancy (including miscarriages, terminations, ectopic pregnancies, preterm and full term deliveries) that has been diagnosed with primary infertility Receives: Device: Shear wave elastography measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shear wave elastography parameters
shear wave elastography measurements in kilopascals
Measured: 3-4 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start6 Feb 2025
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Infertility (IVF Patients)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816381
- Sponsor's protocol ID
- 2401-BRG-003-FB
- Acronym
- QUEST
- Status last verified
- Jun 2026
- First submitted
- 4 Feb 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
6. https://www.sart.org/patients/a-patients-guide-to-assisted-reproductive-technology/general-information/success-rates/
Vora Z, Manchanda S, Sharma R, Das CJ, Hari S, Mathur S, Kumar S, Kachhawa G, Khan MA. Transvaginal Shear Wave Elastography for Assessment of Endometrial and Subendometrial Pathologies: A Prospective Pilot Study. J Ultrasound Med. 2022 Jan;41(1):61-70. doi: 10.1002/jum.15679. Epub 2021 Mar 1.
PubMed 33645765Shao J, Shi G, Qi Z, Zheng J, Chen S. Advancements in the Application of Ultrasound Elastography in the Cervix. Ultrasound Med Biol. 2021 Aug;47(8):2048-2063. doi: 10.1016/j.ultrasmedbio.2021.04.009. Epub 2021 May 26.
PubMed 34049726Van den Bosch T, de Bruijn AM, de Leeuw RA, Dueholm M, Exacoustos C, Valentin L, Bourne T, Timmerman D, Huirne JAF. Sonographic classification and reporting system for diagnosing adenomyosis. Ultrasound Obstet Gynecol. 2019 May;53(5):576-582. doi: 10.1002/uog.19096. No abstract available.
PubMed 29790217Soliman AA, Wojcinski S, Degenhardt F. Ultrasonographic examination of the endometrium and myometrium using acoustic radiation force impulse (ARFI) imaging technology: An initial experience with a new method. Clin Hemorheol Microcirc. 2015;59(3):235-43. doi: 10.3233/CH-141842.
PubMed 24840338Kabukcu C, Cabus U, Oztekin O, Fenkci V. The strain rate of endometrium measured by real-time sonoelastography as a predictive marker for pregnancy in gonadotropin stimulated intrauterine insemination cycles. J Obstet Gynaecol Res. 2021 Oct;47(10):3561-3570. doi: 10.1111/jog.14921. Epub 2021 Jul 12.
PubMed 34254413Batur A, Yavuz A, Ozgokce M, Bora A, Bulut MD, Arslan H, Alpaslan M. The utility of ultrasound elastography in differentiation of endometriomas and hemorrhagic ovarian cysts. J Med Ultrason (2001). 2016 Jul;43(3):395-400. doi: 10.1007/s10396-016-0701-5. Epub 2016 Feb 15.
PubMed 26880060Swierkowski-Blanchard N, Boitrelle F, Alter L, Selva J, Quibel T, Torre A. Uterine contractility and elastography as prognostic factors for pregnancy after intrauterine insemination. Fertil Steril. 2017 Apr;107(4):961-968.e3. doi: 10.1016/j.fertnstert.2017.02.002. Epub 2017 Mar 7.
PubMed 28283264Altunkeser A, Inal ZO, Baran N. Evaluation of Ovaries in Patients with Polycystic Ovary Syndrome using Shear Wave Elastography. Curr Med Imaging. 2020;16(5):578-583. doi: 10.2174/1573405615666190114150538.
PubMed 32484092Raga F, Bonilla-Musoles F, Casan EM, Klein O, Bonilla F. Assessment of endometrial volume by three-dimensional ultrasound prior to embryo transfer: clues to endometrial receptivity. Hum Reprod. 1999 Nov;14(11):2851-4. doi: 10.1093/humrep/14.11.2851.
PubMed 10548635Barrett F, Willson S, Werner M. Advancements in the application of uterine ultrasound elastography. Curr Opin Obstet Gynecol. 2024 Jun 1;36(3):181-185. doi: 10.1097/GCO.0000000000000949. Epub 2024 Mar 26.
PubMed 38656810Hawkins Bressler L, Steiner A. Anti-Mullerian hormone as a predictor of reproductive potential. Curr Opin Endocrinol Diabetes Obes. 2018 Dec;25(6):385-390. doi: 10.1097/MED.0000000000000440.
PubMed 30299431Zaniker 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 38609185Cedars MI. Evaluation of Female Fertility-AMH and Ovarian Reserve Testing. J Clin Endocrinol Metab. 2022 May 17;107(6):1510-1519. doi: 10.1210/clinem/dgac039.
PubMed 35100616Scott RT Jr, Upham KM, Forman EJ, Hong KH, Scott KL, Taylor D, Tao X, Treff NR. Blastocyst biopsy with comprehensive chromosome screening and fresh embryo transfer significantly increases in vitro fertilization implantation and delivery rates: a randomized controlled trial. Fertil Steril. 2013 Sep;100(3):697-703. doi: 10.1016/j.fertnstert.2013.04.035. Epub 2013 Jun 1.
PubMed 23731996
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Uterine and Ovarian Tissue Stiffness Via Shear Wave Elastography in Non-Infertile, Fertile, and Infertile Women With Normal Anatomy Across the Menstrual Cycle: A Pilot Study
- ClinicalTrials.gov ID
- NCT06816381
- Acronym / sponsor ID
- QUEST / 2401-BRG-003-FB
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Feb 2025 (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 is aiming to characterize the elasticity of the female reproductive tract including the uterus, cervix and ovary using shear wave elastography at different times during the menstrual cycle and define the standard reference range of normal uterine and ovarian elasticity. By doing so, the potential of using shear wave elastography to diagnose and predict outcomes for patients seeking fertility treatment might be established.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nulliparous Women with No Known infertility | – | –Female patients with normal menstrual cycles, normal ovarian and uterine anatomy and with no known prior pregnancy (including miscarriages, terminations, ectopic pregnancies, preterm and full term deliveries) |
| Gravid Women with No Known infertility | – | –Female patients with normal menstrual cycles, normal ovarian and uterine anatomy with at least one prior full term vaginal delivery with no known infertility |
| Primary Infertile Women Without Uterine Factor Infertility | – | Device: Shear wave elastography measurementsFemale patients with normal menstrual cycles, normal ovarian and uterine anatomy and with no known prior pregnancy (including miscarriages, terminations, ectopic pregnancies, preterm and full term deliveries) that has been diagnosed with primary infertility |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Nulliparous women with no known infertility, gravid women with no known infertility and primary infertile women without uterine factor infertility
Key inclusion criteria (11 listed)
- Patients with normal menstrual cycles lasting 28-34 days
- Patients with normal uterine anatomy
- Patients with no prior pregnancy history including miscarriages, terminations, ectopic pregnancies, preterm deliveries, or full-term deliveries
- Patient who have no known infertility (i.e. women who have not tried to conceive)
- Patients with normal menstrual cycles lasting 28 days to 34 days.
Key exclusion criteria (37 listed)
- BMI ≥ 35
- Current use of intrauterine devices (IUDs), hormonal implants, or hormonal birth control medications. Participants on hormonal birth control interested in study participation may be included following one month of discontinuation of hormonal medication.
- History of uterine surgery (i.e hysteroscopy, dilation and curettage, myomectomy)
- History of ovarian surgery (i.e ovarian cystectomy, oophorectomy, removal of -endometrioma)
- History of surgically-confirmed or clinically suspected endometriosis or ultrasound evidence of endometriosis (i.e endometrioma)
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 |
|---|---|---|
| Shear wave elastography measurementsShear wave elastography measurements in kilopascals via ultrasound | Device | Primary Infertile Women Without Uterine Factor Infertility |
Primary outcome
Shear wave elastography parameters
Time frame: 3-4 months from enrollment
shear wave elastography measurements in kilopascals
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 3 Jun 2026.
- Background6. https://www.sart.org/patients/a-patients-guide-to-assisted-reproductive-technology/general-information/success-rates/
- Background: PubMed 33645765Vora Z, Manchanda S, Sharma R, Das CJ, Hari S, Mathur S, Kumar S, Kachhawa G, Khan MA. Transvaginal Shear Wave Elastography for Assessment of Endometrial and Subendometrial Pathologies: A Prospective Pilot Study. J Ultrasound Med. 2022 Jan;41(1):61-70. doi: 10.1002/jum.15679. Epub 2021 Mar 1.
- Background: PubMed 34049726Shao J, Shi G, Qi Z, Zheng J, Chen S. Advancements in the Application of Ultrasound Elastography in the Cervix. Ultrasound Med Biol. 2021 Aug;47(8):2048-2063. doi: 10.1016/j.ultrasmedbio.2021.04.009. Epub 2021 May 26.
- Background: PubMed 29790217Van den Bosch T, de Bruijn AM, de Leeuw RA, Dueholm M, Exacoustos C, Valentin L, Bourne T, Timmerman D, Huirne JAF. Sonographic classification and reporting system for diagnosing adenomyosis. Ultrasound Obstet Gynecol. 2019 May;53(5):576-582. doi: 10.1002/uog.19096. No abstract available.
- Background: PubMed 24840338Soliman AA, Wojcinski S, Degenhardt F. Ultrasonographic examination of the endometrium and myometrium using acoustic radiation force impulse (ARFI) imaging technology: An initial experience with a new method. Clin Hemorheol Microcirc. 2015;59(3):235-43. doi: 10.3233/CH-141842.
- Background: PubMed 34254413Kabukcu C, Cabus U, Oztekin O, Fenkci V. The strain rate of endometrium measured by real-time sonoelastography as a predictive marker for pregnancy in gonadotropin stimulated intrauterine insemination cycles. J Obstet Gynaecol Res. 2021 Oct;47(10):3561-3570. doi: 10.1111/jog.14921. Epub 2021 Jul 12.
- Background: PubMed 26880060Batur A, Yavuz A, Ozgokce M, Bora A, Bulut MD, Arslan H, Alpaslan M. The utility of ultrasound elastography in differentiation of endometriomas and hemorrhagic ovarian cysts. J Med Ultrason (2001). 2016 Jul;43(3):395-400. doi: 10.1007/s10396-016-0701-5. Epub 2016 Feb 15.
- Background: PubMed 28283264Swierkowski-Blanchard N, Boitrelle F, Alter L, Selva J, Quibel T, Torre A. Uterine contractility and elastography as prognostic factors for pregnancy after intrauterine insemination. Fertil Steril. 2017 Apr;107(4):961-968.e3. doi: 10.1016/j.fertnstert.2017.02.002. Epub 2017 Mar 7.
- Background: PubMed 32484092Altunkeser A, Inal ZO, Baran N. Evaluation of Ovaries in Patients with Polycystic Ovary Syndrome using Shear Wave Elastography. Curr Med Imaging. 2020;16(5):578-583. doi: 10.2174/1573405615666190114150538.
- Background: PubMed 10548635Raga F, Bonilla-Musoles F, Casan EM, Klein O, Bonilla F. Assessment of endometrial volume by three-dimensional ultrasound prior to embryo transfer: clues to endometrial receptivity. Hum Reprod. 1999 Nov;14(11):2851-4. doi: 10.1093/humrep/14.11.2851.
- Background: PubMed 38656810Barrett F, Willson S, Werner M. Advancements in the application of uterine ultrasound elastography. Curr Opin Obstet Gynecol. 2024 Jun 1;36(3):181-185. doi: 10.1097/GCO.0000000000000949. Epub 2024 Mar 26.
- Background: PubMed 30299431Hawkins Bressler L, Steiner A. Anti-Mullerian hormone as a predictor of reproductive potential. Curr Opin Endocrinol Diabetes Obes. 2018 Dec;25(6):385-390. doi: 10.1097/MED.0000000000000440.
- Individual participant dataSharing planned: No
Related trials for Infertility (IVF Patients)
Recruiting
225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women
Infertility (IVF Patients), Infertility Assisted Reproductive Technology
Recruiting
The Effects of Carnitine Supplementation on Oocytes in Women Undergoing IVF Process
Infertility (IVF Patients)
Not yet recruiting
Intra-ovarian CAPA-IVM vs Standard IVM
Infertility (IVF Patients), Infertility
Not yet recruitingObservational study
Endometrial Immune Profile in Recurrent Implantation Failure
Recurrent Implantation Failure, Infertility (IVF Patients)
RecruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility (IVF Patients) and Infertility Assisted Reproductive Technology, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
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 11 inclusion and 37 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: looking for participants now, as of the sponsor's last update on 3 Jun 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 United States. 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 Caroline Zuckerman, BS, BSN, RN (9736562841, clinicalresearchteam@ivirma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shear wave elastography parameters (time frame: 3-4 months from enrollment). 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 NCT06816381, which also lists 16 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 3 Jun 2026.