Infertility
Conditions
Brief summary
The proposed study is a single-blind randomized controlled trial which seeks to characterize implantation rates following embryo vitrification and subsequent warming with both slush nitrogen and liquid nitrogen. After warming, implantation rates and pregnancy outcomes will be assessed.
Detailed description
The purpose of this study is to determine if slush nitrogen for embryo vitrification results in higher sustained implantation rates compared to the conventional use of liquid nitrogen. Routine ovarian stimulation, oocyte retrieval and embryology care will ensue. All blastocyst stage embryos will be randomized to either the control (liquid nitrogen) or intervention group (slush nitrogen) and vitrified after trophectoderm biopsy has been performed for PGT-A (preimplantation genetic testing for aneuploidy). A single, chromosomally normal embryo will be transferred in a subsequent frozen embryo transfer cycle per routine. Implantation rates and pregnancy outcomes will be assessed.
Interventions
blastocyst stage embryos will be vitrified via slush nitrogen
Sponsors
Reproductive Medicine Associates of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
Major Inclusion Criteria for participants: 1. Patients undergoing IVF stimulation cycle with plan for subsequent frozen embryo transfer (FET) 2. Patients electing preimplantation genetic testing for aneuploidy (PGT-A) 3. Couples electing single embryo transfer (SET) Major
Exclusion criteria
for participants: 1. All patients who do not voluntarily give their written consent for participation 2. Under 18 years old, above 42 years old 3. BMI \> 35 4. Maximum day 3 Follicle stimulating hormone (FSH) level of 12 or higher 5. Anti-mullerian hormone (AMH) level less than 1.0 g/mL, tested within previous year 6. Total basal antral follicle count less than 6 follicles 7. Failed more than one previous FET cycle 8. Use of oocyte donation 9. Use of gestational carrier 10. Presence of hydrosalpinges that communicate with endometrial cavity 11. Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid 12. Uncorrected uterine factor infertility (uterine anomaly, submucosal myomas, uterine septum) 13. Single gene disorder chromosomal rearrangement requiring a more detailed embryonic genetic analysis 14. Male partner with \<100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable) 15. Use of surgical procedures to obtain sperm 16. Couples undergoing IVF for fertility preservation with no immediate plan for subsequent FET (embryo banking) 17. Sex selection 18. Personal history of repeated pregnancy loss (two or more unexplained clinical losses defined by presence of fetal heartbeat)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sustained implantation rate | approximately 8 weeks gestation age | fetal heart beat present upon discharge at 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical pregnancy rate | usually by 5 weeks gestational age | presence of gestational sac in uterus |
| miscarriage rate | 1-8 months dependent on gestational age of loss | pregnancy loss |
| live birth rate | 9 months | delivery of live infant |
Countries
United States
Outcome results
None listed