Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen

Study Overview
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Brief Summary
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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
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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.

Official Title
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Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen

Conditions
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Infertility

Intervention / Treatment
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* Other: Vitrification via slush nitrogen


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitrification via slush nitrogen<br>Blastocyst stage embryos will be vitrified via slush nitrogen | Other: Vitrification via slush nitrogen<br>* blastocyst stage embryos will be vitrified via slush nitrogen<br>|
| No Intervention: Vitrification via liquid nitrogen<br>Blastocyst stage embryos will be vitrified via conventional liquid nitrogen. This is the current standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sustained implantation rate | fetal heart beat present upon discharge at 8 weeks | approximately 8 weeks gestation age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate | presence of gestational sac in uterus | usually by 5 weeks gestational age | 
| miscarriage rate | pregnancy loss | 1-8 months dependent on gestational age of loss | 
| live birth rate | delivery of live infant | 9 months |