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OpenTrials
Completed

NCT Number: NCT04496284

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.

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Reproductive Medicine Assoicates of New Jersey

Basking Ridge, New Jersey, 07920, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vitrification via slush nitrogen

Other

blastocyst stage embryos will be vitrified via slush nitrogen

Primary outcomes

  1. sustained implantation rate

    Time frame: approximately 8 weeks gestation age

    fetal heart beat present upon discharge at 8 weeks

Secondary outcomes

  1. clinical pregnancy rate

    Time frame: usually by 5 weeks gestational age

    presence of gestational sac in uterus

  2. miscarriage rate

    Time frame: 1-8 months dependent on gestational age of loss

    pregnancy loss

  3. live birth rate

    Time frame: 9 months

    delivery of live infant

Sponsors and collaborators

Lead sponsor

Reproductive Medicine Associates of New Jersey

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 3, 2020
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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