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Clinical Trials/NCT05397912
NCT05397912
Completed
Not Applicable

Uterine Elastography: a Potential Predictor of Embryo Transfer Success

Reproductive Medicine Associates of New Jersey1 site in 1 country162 target enrollmentJune 15, 2022
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ConditionsInfertility, Female

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility, Female
Sponsor
Reproductive Medicine Associates of New Jersey
Enrollment
162
Locations
1
Primary Endpoint
Sustained Implantation Rate
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2022
End Date
September 1, 2023
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •Gestational carriers
  • •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

Outcomes

Primary Outcomes

Sustained Implantation Rate

Time Frame: 6 weeks after embryo transfer

number of fetal heart beats at time of discharge ultrasound

Secondary Outcomes

  • Clinical Pregnancy(2-4 weeks after embryo transfer)
  • Clinical Pregnancy Loss(2-40 weeks after embryo transfer)
  • Chemical Pregnancy(8-10 days after embryo transfer)

Study Sites (1)

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