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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04496284
• Other study ID #: RMA-2020-03
• Status: Completed
• Phase: N/A
• Start date: September 5, 2020
• Est. completion date: December 20, 2022

Study information

• Verified date: May 2023
• Source: Reproductive Medicine Associates of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: December 20, 2022
• Est. primary completion date: May 3, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
United States	Reproductive Medicine Assoicates of New Jersey	Basking Ridge	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sustained implantation rate	fetal heart beat present upon discharge at 8 weeks	approximately 8 weeks gestation age
Secondary	clinical pregnancy rate	presence of gestational sac in uterus	usually by 5 weeks gestational age
Secondary	miscarriage rate	pregnancy loss	1-8 months dependent on gestational age of loss
Secondary	live birth rate	delivery of live infant	9 months