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OpenTrials
Completed

NCT Number: NCT05397912

Uterine Elastography: a Potential Predictor of Embryo Transfer Success

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

Uterine Elastography

Diagnostic Test

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

Primary outcomes

  1. Sustained Implantation Rate

    Time frame: 6 weeks after embryo transfer

    number of fetal heart beats at time of discharge ultrasound

Secondary outcomes

  1. Chemical Pregnancy

    Time frame: 8-10 days after embryo transfer

    Positive serum bHCG level

  2. Clinical Pregnancy

    Time frame: 2-4 weeks after embryo transfer

    presence of gestational sac on ultrasound

  3. Clinical Pregnancy Loss

    Time frame: 2-40 weeks after embryo transfer

    loss of gestational sac, yolk sac, fetal pole, fetal heart beat on ultrasound after being present

Sponsors and collaborators

Lead sponsor

Reproductive Medicine Associates of New Jersey

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 31, 2022
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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