Clinical trial NCT04496284: Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen
Official title: Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 253
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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)

Primary outcomes:
measure: sustained implantation rate
timeFrame: approximately 8 weeks gestation age
Secondary outcomes:
measure: clinical pregnancy rate
timeFrame: usually by 5 weeks gestational age
measure: miscarriage rate
timeFrame: 1-8 months dependent on gestational age of loss
measure: live birth rate
timeFrame: 9 months
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Reproductive Medicine Assoicates of New Jersey
state: New Jersey
Study officials:
References: