Quantifying Uterine Elastography in Menstruating Women

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Reproductive Medicine Associates of New Jersey
Study ID
NCT06816381
Status
Recruiting
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Conditions

  • Infertility (IVF Patients)
  • Infertility Assisted Reproductive Technology

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Shear wave elastography measurements — DEVICE
    Shear wave elastography measurements in kilopascals via ultrasound

Study Details

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.

Key Dates

Start date
Feb 6, 2025
Status verified
Jun 2026
Primary completion
Aug 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: 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)
  • Arm: 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
  • Arm: 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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
RMABasking RidgeNew Jersey07920
Christine Whitehead, MS, BSN, RN
[email protected]
9736562841

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RMA· Basking Ridge, NJ

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