Uterine Elastography: a Potential Predictor of Embryo Transfer Success

NCT05397912 | Completed

• 1 other identifier: RMA-2022-02
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

• Sustained Implantation Rate

  number of fetal heart beats at time of discharge ultrasound

  6 weeks after embryo transfer

Secondary Outcomes (3)

• Chemical Pregnancy

  8-10 days after embryo transfer

• Clinical Pregnancy

  2-4 weeks after embryo transfer

• Clinical Pregnancy Loss

  2-40 weeks after embryo transfer

Study Arms (1)

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

Interventions

Uterine Elastography DIAGNOSTIC_TEST

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

Women undergoing euploid, single frozen embryo transfer

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Reproductive Medicine Associates of New Jersey: lead

Study Sites (1)

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Location

Related Publications (1)

• 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.

  PMID: 39999405 DERIVED

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Marie Werner, MD

  Reproductive Medicine Associates of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: May 31, 2022
• Study Start: June 15, 2022
• Primary Completion: January 12, 2023
• Study Completion: September 1, 2023
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)