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Quantifying Uterine Elastography in Menstruating Women | Clinical Trials | Clareo Health

RECRUITING

Quantifying Uterine Elastography in Menstruating Women

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

NCT06816381•Reproductive Medicine Associates of New Jersey

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Group A
•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)
•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.
•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)
+2 more criteria

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.
+27 more criteria

Locations (1)

RMA

Basking Ridge, New Jersey, United States

Key Dates

Start Date

February 6, 2025

Primary Completion Date

August 1, 2026

Completion Date

December 1, 2026

Last Updated

February 13, 2025

Enrollment

ESTIMATED participants

Conditions

Infertility (IVF Patients)Infertility Assisted Reproductive Technology

Interventions

Shear wave elastography measurements

DEVICE

Contacts

Caroline Zuckerman, BS, BSN, RN

CONTACT

9736562841 clinicalresearchteam@ivirma.com

Christine Whitehead, MS, BSN, RN

CONTACT

9736562841 clinicalresearchteam@ivirma.com

Biological Aging Hallmarks-Guided Integrative TCM and Conventional Medicine in Post-Treatment Unexplained Female Infertility

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Idiopathic InfertilityInfertility Unexplained+3 more

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RECRUITINGNA

A Prospective Study to Evaluate the Outcome of the Aurora Test Used With Blastocyst Transfer in an ICSI Cycle (Aurora-Blasto)

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Infertility Assisted Reproductive Technology

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Quantifying Uterine Elastography in Menstruating Women

Inclusion Criteria

Exclusion Criteria

Biological Aging Hallmarks-Guided Integrative TCM and Conventional Medicine in Post-Treatment Unexplained Female Infertility

A Prospective Study to Evaluate the Outcome of the Aurora Test Used With Blastocyst Transfer in an ICSI Cycle (Aurora-Blasto)

Ketorolac Use and Fresh Embryo Transfer Outcomes

An Advanced Decision Support Tool for Personalized Medicine for IVF Using Modeling and Optimization for Provera

Language Matters: Exploring the Impact of Language Concordance on Fertility Treatment Progression

The Effect of Mindfulness-Based Lifestyle Support Program on Infertile Women