Status:
COMPLETED
Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen
Lead Sponsor:
Reproductive Medicine Associates of New Jersey
Conditions:
Infertility
Eligibility:
FEMALE
18-42 years
Phase:
NA
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 liqui...
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...
Eligibility Criteria
Inclusion
- Major Inclusion Criteria for participants:
- Patients undergoing IVF stimulation cycle with plan for subsequent frozen embryo transfer (FET)
- Patients electing preimplantation genetic testing for aneuploidy (PGT-A)
- Couples electing single embryo transfer (SET)
- Major Exclusion Criteria for participants:
- All patients who do not voluntarily give their written consent for participation
- Under 18 years old, above 42 years old
- BMI \> 35
- Maximum day 3 Follicle stimulating hormone (FSH) level of 12 or higher
- Anti-mullerian hormone (AMH) level less than 1.0 g/mL, tested within previous year
- Total basal antral follicle count less than 6 follicles
- Failed more than one previous FET cycle
- Use of oocyte donation
- Use of gestational carrier
- Presence of hydrosalpinges that communicate with endometrial cavity
- Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid
- Uncorrected uterine factor infertility (uterine anomaly, submucosal myomas, uterine septum)
- Single gene disorder chromosomal rearrangement requiring a more detailed embryonic genetic analysis
- Male partner with \<100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
- Use of surgical procedures to obtain sperm
- Couples undergoing IVF for fertility preservation with no immediate plan for subsequent FET (embryo banking)
- Sex selection
- Personal history of repeated pregnancy loss (two or more unexplained clinical losses defined by presence of fetal heartbeat)
Exclusion
Key Trial Info
Start Date :
September 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2022
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT04496284
Start Date
September 5 2020
End Date
December 20 2022
Last Update
May 3 2023
Active Locations (1)
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1
Reproductive Medicine Assoicates of New Jersey
Basking Ridge, New Jersey, United States, 07920