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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 3, 2022

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

  • Other: Vitrification via slush nitrogen
    • blastocyst stage embryos will be vitrified via slush nitrogen

Arms, Groups and Cohorts

  • Experimental: Vitrification via slush nitrogen
    • Blastocyst stage embryos will be vitrified via slush nitrogen
  • No Intervention: Vitrification via liquid nitrogen
    • Blastocyst stage embryos will be vitrified via conventional liquid nitrogen. This is the current standard of care.

Clinical Trial Outcome Measures

Primary Measures

  • sustained implantation rate
    • Time Frame: approximately 8 weeks gestation age
    • fetal heart beat present upon discharge at 8 weeks

Secondary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 42 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Reproductive Medicine Associates of New Jersey
  • Provider of Information About this Clinical Study
    • Sponsor

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