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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06816381

Acronym

QUEST

Enrollment

Registered

2025-02-10

Start date

2025-02-06

Completion date

2027-12-01

Last updated

2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility Assisted Reproductive Technology, Infertility (IVF Patients)

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.

Interventions

DEVICEShear wave elastography measurements

Shear wave elastography measurements in kilopascals via ultrasound

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
Shear wave elastography parameters	3-4 months from enrollment	shear wave elastography measurements in kilopascals

Countries

United States

Contacts

CONTACTCaroline Zuckerman, BS, BSN, RN

clinicalresearchteam@ivirma.com9736562841

CONTACTChristine Whitehead, MS, BSN, RN