Uterine Elastography: a Potential Predictor of Embryo Transfer Success

Completed

• Conditions: Infertility, Female
• Interventions: Diagnostic Test: Uterine Elastography

• Registration Number: NCT05397912
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-05-25
• Study First Posted: 2022-05-31
• Study Start: 2022-06-15
• Primary Completion: 2023-01-12
• Study Completion: 2023-09-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 162

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women undergoing euploid, single frozen embryo transfer	Uterine Elastography	Women age 18yo-45yo undergoing euploid, single, frozen embryo transfer with sonographically normal appearing uterus without uterine factor infertility

Primary Outcome Measures

Name	Time	Method
Sustained Implantation Rate	6 weeks after embryo transfer	number of fetal heart beats at time of discharge ultrasound

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Reproductive Medicine Associates of New Jersey; 🇺🇸 Basking Ridge, New Jersey, United States