Actively Recruiting

Age: 18Years - 45Years
FEMALE
Healthy Volunteers
ID06816381

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

Led by Reproductive Medicine Associates of New Jersey · Updated on 2026-06-03

40

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the elasticity of the female reproductive organs, including the uterus, cervix, and ovaries, by using shear wave elastography during different times of the menstrual cycle. The study aims to establish normal reference ranges for uterine and ovarian tissue stiffness. This knowledge may help in diagnosing and predicting outcomes for women seeking fertility treatments. The study involves measuring tissue stiffness with shear wave elastography, a device that uses ultrasound to assess elasticity in kilopascals. Participants are grouped into three categories: women with normal menstrual cycles and no prior pregnancy or infertility; women with normal cycles and at least one prior full-term vaginal delivery without infertility; and women with normal cycles and diagnosed primary infertility without uterine factor infertility. Each participant undergoes this assessment over approximately 3 to 4 months from enrollment. Participants will be monitored through shear wave elastography measurements to observe changes throughout their menstrual cycles. The primary outcome is the elastography parameters recorded within 3 to 4 months. This observational study includes women aged 18 to 45 years with normal uterine and ovarian anatomy. The study also involves detailed eligibility assessments to ensure participants meet criteria related to menstrual cycle regularity, anatomy, and reproductive history.

CONDITIONS

Brief Title

Quantifying Uterine Elastography in Menstruating Women

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 to 45 years
  • Normal menstrual cycles lasting 28 to 34 days
  • Normal uterine and ovarian anatomy without gross pathology
  • Group-specific criteria:
  • Group A: No prior pregnancy and no known infertility
  • Group B: At least one prior full-term vaginal delivery without infertility
  • Group C: No prior pregnancy with diagnosis of primary infertility and attempted conception for specified durations
  • Participants on hormonal birth control must discontinue use for at least one month before participation
Not Eligible

You will not qualify if you...

  • Body Mass Index (BMI) of 35 or higher
  • Current use of intrauterine devices (IUDs), hormonal implants, or hormonal birth control medications (unless discontinued for one month)
  • History of uterine surgery such as hysteroscopy, dilation and curettage, or myomectomy
  • History of ovarian surgery including cystectomy, oophorectomy, or removal of endometrioma
  • History or ultrasound evidence of endometriosis
  • Presence or history of uterine anomalies
  • Ultrasound evidence or history of communicating hydrosalpinx, leiomyomas, or adenomyosis
  • Ultrasound evidence of ovarian pathology including mature teratoma/dermoid cyst, persistent functional cysts larger than 2 cm, or ovarian cancer
  • For Group B: History of cesarean section or secondary infertility
  • For Group C: History of three or more failed euploid embryo transfers or severe male factor infertility

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 3 to 4 months from enrollment

Participants undergo shear wave elastography measurements via ultrasound to assess uterine and ovarian tissue stiffness.

Multiple visits timed across the menstrual cycle

Trial Site Locations

Total: 1 location

1

RMA

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

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Research Team

C

Caroline Zuckerman, BS, BSN, RN

C

Christine Whitehead, MS, BSN, RN

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

Transvaginal Shear Wave Elastography for Assessment of Endometrial and Subendometrial Pathologies: A Prospective Pilot Study.

Zainab Vora, Smita Manchanda, Raju Sharma...

https://pubmed.ncbi.nlm.nih.gov/33645765

Ultrasonographic examination of the endometrium and myometrium using acoustic radiation force impulse (ARFI) imaging technology: An initial experience with a new method.

Amr A Soliman, Sebastian Wojcinski, Friedrich Degenhardt

https://pubmed.ncbi.nlm.nih.gov/24840338

The strain rate of endometrium measured by real-time sonoelastography as a predictive marker for pregnancy in gonadotropin stimulated intrauterine insemination cycles.

Cihan Kabukçu, Ümit Çabuş, Özer Öztekin...

https://pubmed.ncbi.nlm.nih.gov/34254413

Uterine contractility and elastography as prognostic factors for pregnancy after intrauterine insemination.

Nelly Swierkowski-Blanchard, Florence Boitrelle, Laura Alter...

https://pubmed.ncbi.nlm.nih.gov/28283264

Assessment of endometrial volume by three-dimensional ultrasound prior to embryo transfer: clues to endometrial receptivity.

F Raga, F Bonilla-Musoles, E M Casañ...

https://pubmed.ncbi.nlm.nih.gov/10548635