Quantifying Uterine Elastography in Menstruating Women

NCT06816381 | Recruiting FDA Device

• 1 other identifier: 2401-BRG-003-FB
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility (IVF Patients); Infertility Assisted Reproductive Technology

Outcome Measures

Primary Outcomes (1)

• Shear wave elastography parameters

  shear wave elastography measurements in kilopascals

  3-4 months from enrollment

Study Arms (3)

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)

Device: Shear wave elastography measurements

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

Device: Shear wave elastography measurements

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

Shear wave elastography measurements DEVICE

Shear wave elastography measurements in kilopascals via ultrasound

Gravid Women with No Known infertility; Nulliparous Women with No Known infertility; Primary Infertile Women Without Uterine Factor Infertility

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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
• 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.
• BMI ≥ 35

Sponsors & Collaborators

• Reproductive Medicine Associates of New Jersey: lead

Study Sites (1)

RMA

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Related Publications (16)

• 6. https://www.sart.org/patients/a-patients-guide-to-assisted-reproductive-technology/general-information/success-rates/

  BACKGROUND

• 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.

  PMID: 33645765 BACKGROUND

• 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.

  PMID: 34049726 BACKGROUND

• 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.

  PMID: 29790217 BACKGROUND

• 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.

  PMID: 24840338 BACKGROUND

• 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.

  PMID: 34254413 BACKGROUND

• 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.

  PMID: 26880060 BACKGROUND

• 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.

  PMID: 28283264 BACKGROUND

• 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.

  PMID: 32484092 BACKGROUND

• 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.

  PMID: 10548635 BACKGROUND

• 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.

  PMID: 38656810 BACKGROUND

• 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.

  PMID: 30299431 BACKGROUND

• 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.

  PMID: 38609185 BACKGROUND

• 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.

  PMID: 35100616 BACKGROUND

• 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.

  PMID: 23731996 BACKGROUND

• 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.

  PMID: 22305103 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood samples obtained from participants

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Caroline Zuckerman, BS, BSN, RN

CONTACT

9736562841; clinicalresearchteam@ivirma.com

Christine Whitehead, MS, BSN, RN

CONTACT

9736562841; clinicalresearchteam@ivirma.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: February 6, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)