Uterine Elastography: a Potential Predictor of Embryo Transfer Success

Infertility, Female Clinical Trial

Official title:

Uterine Elastography: a Potential Predictor of Embryo Transfer Success

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05397912
• Other study ID #: RMA-2022-02
• Status: Active, not recruiting
• Start date: June 15, 2022
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: Reproductive Medicine Associates of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 162
• Est. completion date: December 2023
• Est. primary completion date: January 12, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Diagnostic Test:
• Uterine Elastography
Shear wave elastography data will be obtained at the transvaginal ultrasound visit the day prior to frozen embryo transfer

Locations

Country	Name	City	State
United States	Reproductive Medicine Associates of New Jersey	Basking Ridge	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Implantation Rate	number of fetal heart beats at time of discharge ultrasound	6 weeks after embryo transfer
Secondary	Chemical Pregnancy	Positive serum bHCG level	8-10 days after embryo transfer
Secondary	Clinical Pregnancy	presence of gestational sac on ultrasound	2-4 weeks after embryo transfer
Secondary	Clinical Pregnancy Loss	loss of gestational sac, yolk sac, fetal pole, fetal heart beat on ultrasound after being present	2-40 weeks after embryo transfer