Uterine Elastography: a Potential Predictor of Embryo Transfer Success

February 4, 2025 updated by: Reproductive Medicine Associates of New Jersey
To determine if the mean elasticity value (measured in kilopascals, kPa) of a patient's endometrium, myometrium and cervix in a sonographically normal appearing uterus predict frozen embryo transfer (FET) success and long term reproductive outcomes when measured the day prior to FET.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

162

Contacts and Locations

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

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Reproductive Medicine Associates of new Jersey

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

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients presenting to one of our offices for an ultrasound the day prior to embryo transfer will be reviewed for inclusion. Patients will be undergoing euploid, single, frozen embryo transfer.

Description

Inclusion Criteria:

  1. Female patients, 18yo-45yo, presenting for ultrasound the day prior to embryo transfer
  2. Patients planning to undergo single embryo transfer (SET) of a euploid embryo by Preimplantation genetic testing for aneuploidy (PGT-A)
  3. Uterine evaluation prior to transfer (saline sonogram or hysteroscopy) within 1 year
  4. Egg recipients

Exclusion Criteria:

  1. Gestational carriers
  2. BMI > 35
  3. Diagnosis of a uterine anomaly
  4. History of uterine surgery, excluding polypectomy, c-section, D&C
  5. Communicating hydrosalpinx
  6. Transfer of an embryo of unknown ploidy status or embryos of undetermined safety
  7. Surgically retrieved sperm
  8. Embryos that were cryopreserved on day 7 of development
  9. Poor quality embryos defined by modified Gardner grading criteria used in the embryology lab
  10. Sonographically abnormal appearing uteri, including distortions from leiomyomas and thin endometrium

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
Intervention / Treatment
Women undergoing euploid, single frozen embryo transfer
Women age 18yo-45yo undergoing euploid, single, frozen embryo transfer with sonographically normal appearing uterus without uterine factor infertility
Diagnostic test: Uterine Elastography
Shear wave elastography data will be obtained at the transvaginal ultrasound visit the day prior to frozen embryo transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained Implantation Rate
Time Frame: 6 weeks after embryo transfer
number of fetal heart beats at time of discharge ultrasound
6 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chemical Pregnancy
Time Frame: 8-10 days after embryo transfer
Positive serum bHCG level
8-10 days after embryo transfer
Clinical Pregnancy
Time Frame: 2-4 weeks after embryo transfer
presence of gestational sac on ultrasound
2-4 weeks after embryo transfer
Clinical Pregnancy Loss
Time Frame: 2-40 weeks after embryo transfer
loss of gestational sac, yolk sac, fetal pole, fetal heart beat on ultrasound after being present
2-40 weeks after embryo transfer

Collaborators and Investigators

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

Sponsor

Reproductive Medicine Associates of New Jersey

Investigators

  • Principal Investigator: Marie Werner, MD, Reproductive Medicine Associates of new Jersey

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)

June 15, 2022

Primary Completion (Actual)

January 12, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

May 25, 2022

First Submitted That Met QC Criteria

May 25, 2022

First Posted (Actual)

May 31, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMA-2022-02

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

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Infertility, Female

Clinical Trials on Uterine Elastography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe