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Recruiting NCT06816381

Quantifying Uterine Elastography in Menstruating Women

— Observational Infertility (IVF Patients) Infertility Assisted Reproductive Technology

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Shear wave elastography measurements.
Who it may be relevant to
Registry conditions: Infertility (IVF Patients), Infertility Assisted Reproductive Technology. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Device Shear wave elastography measurements
    Shear wave elastography measurements in kilopascals via ultrasound

Primary outcome measures

  • Shear wave elastography parameters [Time frame: 3-4 months from enrollment]

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

  • 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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • RMA — Basking Ridge

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 28283264

Identifiers

NCT: NCT06816381 · 2401-BRG-003-FB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗