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

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 Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Other: Vitrification via slush nitrogen

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.

• Study Type: Interventional
• Enrollment (Actual): 253
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Reproductive Medicine Assoicates of New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitrification via slush nitrogen; Blastocyst stage embryos will be vitrified via slush nitrogen	Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Reproductive Medicine Associates of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2020
• Primary Completion (Actual): May 3, 2022
• Study Completion (Actual): December 20, 2022

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: RMA-2020-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No