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

NCT ID: NCT04496284

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 253 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-05
• Study Completion Date: 2022-12-20

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Vitrification via slush nitrogen

Blastocyst stage embryos will be vitrified via slush nitrogen

Group Type: EXPERIMENTAL

Vitrification via slush nitrogen

Intervention Type: OTHER

blastocyst stage embryos will be vitrified via slush nitrogen

Vitrification via liquid nitrogen

Blastocyst stage embryos will be vitrified via conventional liquid nitrogen. This is the current standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vitrification via slush nitrogen

blastocyst stage embryos will be vitrified via slush nitrogen

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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)

Exclusion Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Reproductive Medicine Associates of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Reproductive Medicine Assoicates of New Jersey

Basking Ridge, New Jersey, United States

Countries

United States

References

Klimczak AM, Osman E, Esbert M, Yildirim RM, Whitehead C, Herlihy NS, Hanson BM, Roberts LM, Seli E, Scott RT Jr. A randomized controlled trial comparing embryo vitrification with slush nitrogen to liquid nitrogen in women undergoing frozen embryo transfer: embryology and clinical outcomes. Hum Reprod. 2025 Mar 1;40(3):426-433. doi: 10.1093/humrep/deaf003.

Reference Type: DERIVED

PMID: 39836897 (View on PubMed)

Other Identifiers

RMA-2020-03

Identifier Type: -

Identifier Source: org_study_id