Infertility, Female
Conditions
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.
Interventions
DIAGNOSTIC_TESTUterine Elastography
Shear wave elastography data will be obtained at the transvaginal ultrasound visit the day prior to frozen embryo transfer
Sponsors
Reproductive Medicine Associates of New Jersey
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Implantation Rate | 6 weeks after embryo transfer | number of fetal heart beats at time of discharge ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chemical Pregnancy | 8-10 days after embryo transfer | Positive serum bHCG level |
| 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 |
Countries
United States
Outcome results
None listed