Uterine Elastography: a Potential Predictor of Embryo Transfer Success

NCT ID: NCT05397912

Last Updated: 2025-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

162 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-15

Study Completion Date

2023-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility, Female

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Uterine Elastography

Intervention Type DIAGNOSTIC_TEST

Shear wave elastography data will be obtained at the transvaginal ultrasound visit the day prior to frozen embryo transfer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Uterine Elastography

Shear wave elastography data will be obtained at the transvaginal ultrasound visit the day prior to frozen embryo transfer

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Reproductive Medicine Associates of New Jersey

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marie Werner, MD

Role: PRINCIPAL_INVESTIGATOR

Reproductive Medicine Associates of New Jersey

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Margolis C, Garrido N, Roberts L, Reig A, Gill P, Willson S, Genovese H, Barrett F, Zuckerman C, Whitehead C, Bergh P, Seli E, Werner M. Mapping the way to successful euploid frozen embryo transfer: a prospective pilot study of uterine elastography. Hum Reprod. 2025 May 1;40(5):895-903. doi: 10.1093/humrep/deaf029.

Reference Type DERIVED
PMID: 39999405 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RMA-2022-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Retrospective Database Studies
NCT01219296 COMPLETED