Quantifying Uterine Elastography in Menstruating Women (QUEST)

June 1, 2026 updated by: Reproductive Medicine Associates of New Jersey

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Nulliparous women with no known infertility, gravid women with no known infertility and primary infertile women without uterine factor infertility

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
Device: Shear wave elastography measurements
Shear wave elastography measurements in kilopascals via ultrasound
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
Device: Shear wave elastography measurements
Shear wave elastography measurements in kilopascals via ultrasound
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
Device: Shear wave elastography measurements
Shear wave elastography measurements in kilopascals via ultrasound

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Shear wave elastography parameters
Time Frame: 3-4 months from enrollment
shear wave elastography measurements in kilopascals
3-4 months from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Reproductive Medicine Associates of New Jersey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 6, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2401-BRG-003-FB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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