ClinicalTrials.gg
RecruitingNCT06816381QUESTUpdated Jun 3, 2026

Quantifying Uterine Elastography in Menstruating Women

An observational study in Infertility (IVF Patients) and Infertility Assisted Reproductive Technology, sponsored by Reproductive Medicine Associates of New Jersey. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by Reproductive Medicine Associates of New Jersey · Observational

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 45 Years
Sex
Female
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Study 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. By doing so, the potential of using shear wave elastography to diagnose and predict outcomes for patients seeking fertility treatment might be established.

02

Conditions studied

  • Infertility (IVF Patients)
  • Infertility Assisted Reproductive Technology

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03

In context

Infertility

2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.

This study's planned enrollment of 40 is below the median of 200 across 592 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Reproductive Medicine Associates of New Jersey is the lead sponsor of 55 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Nulliparous women with no known infertility, gravid women with no known infertility and primary infertile women without uterine factor infertility

Eligibility criteria

Group A

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • ≥ 35
  • Current use of intrauterine devices (IUDs), hormonal implants, or hormonal 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
  • 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

Inclusion Criteria:

  • 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)
  • 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.

Exclusion Criteria

  • 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

Inclusion Criteria:

  • 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.

Exclusion Criteria

  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

    Device: Shear wave elastography measurements

Interventions

  • DeviceShear wave elastography measurements

    Shear wave elastography measurements in kilopascals via ultrasound

06

What researchers measure

Primary outcomes

  1. Shear wave elastography parameters

    shear wave elastography measurements in kilopascals

    Time frame: 3-4 months from enrollment

07

Study locations

1 of 1 sites recruiting
  • RMA
    Basking Ridge, New Jersey 07920, United States
    Recruiting
08

References and documents

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 33645765 ↗
  • Shao 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 34049726 ↗
  • Van 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 29790217 ↗
  • Soliman 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 24840338 ↗
  • Kabukcu 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 34254413 ↗
  • Batur 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 26880060 ↗
  • Swierkowski-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 28283264 ↗
  • Altunkeser 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 32484092 ↗
  • Raga 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 10548635 ↗
  • Barrett 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 38656810 ↗
  • Hawkins 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 30299431 ↗
  • Zaniker 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 38609185 ↗
  • Cedars 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 35100616 ↗
  • Scott 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 ↗
  • Scott RT Jr, Ferry K, Su J, Tao X, Scott K, Treff NR. Comprehensive chromosome screening is highly predictive of the reproductive potential of human embryos: a prospective, blinded, nonselection study. Fertil Steril. 2012 Apr;97(4):870-5. doi: 10.1016/j.fertnstert.2012.01.104. Epub 2012 Feb 2. PubMed 22305103 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06816381
Lead sponsor
Reproductive Medicine Associates of New Jersey
Responsible party
Sponsor
First posted
Feb 10, 2025
Start date
Feb 6, 2025
Primary completion
Aug 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jun 3, 2026

Study contacts

Caroline Zuckerman, BS, BSN, RN
Contact
clinicalresearchteam@ivirma.com
9736562841
Christine Whitehead, MS, BSN, RN
Contact
clinicalresearchteam@ivirma.com
9736562841

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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