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OpenTrials
Completed

NCT Number: NCT04342364

Oocyte Survival After Vitrification With Slush Nitrogen Compared With Liquid Nitrogen

The purpose of this study is to determine if the use of slush nitrogen results in higher post-thaw survival rates for oocytes compared to conventionally used liquid nitrogen.

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Key information

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

About this study

The study is a randomized, controlled trial which seeks to characterize oocyte survival rate following vitrification and subsequent warming with both slush nitrogen and liquid nitrogen. After warming, fertilization and embryology outcomes will be assessed.

Oocyte donors and a single donor sperm source will be utilized. Following enrollment, oocyte donors will undergo ovarian stimulation and oocyte retrieval. The mature (MII) oocytes obtained for each patient will then be assigned a number and randomized via block randomization to one of two treatment groups (liquid nitogen or slush nitrogen). Through block randomization, this will create a paired population of oocytes so that half of each patient's oocytes will undergo cryopreservation with liquid nitrogen and half will undergo cryopreservation with slush nitrogen. Timing of hyaluronidase stripping and vitrification will be consistent with current institutional clinical practice for oocytes.

Following cryopreservation, oocytes will be warmed and intracytoplasmic sperm injection will be performed and subsequent embryology outcomes tracked.

Who can participate

Healthy volunteers accepted: No

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

Major Inclusion Criteria for oocyte donors:

  • Age 30 years or younger who meet institutional criteria to be an oocyte donor.
  • Patients who agree to donate oocytes for research purposes and agree to the study protocol.
  • The subgroup of oocyte donors age 35-38 will not be part of the primary analysis, and therefore will not be required to meet the age criteria listed above. The older group of donors will be chosen as the clinical discretion of the study investigators. No specific ovarian reserve cutoffs will be required, although factors related to ovarian reserve will be taken into consideration.

Major Exclusion Criteria for oocyte donors:

  • Under 18 years old
  • All patients who do not voluntarily give their written consent for participation.
  • Patients who do not meet standard institutional criteria for oocyte donation.
  • A diagnosis of polycystic ovarian syndrome (PCOS).

Treatment and study plan

Vitrification via slush nitrogen

Other

oocytes will be vitrified using slush nitrogen

Vitrification via liquid nitrogen

Other

oocytes will be vitrified using liquid nitrogen which is currently routine practice

Primary outcomes

  1. oocyte survival rate

    Time frame: within 5 minutes post warming

    number of viable oocytes post warming

Secondary outcomes

  1. fertilization rate

    Time frame: 18 hours post injection

    number of zygotes post intracytoplasmic sperm injection procedure

  2. blastulation rate

    Time frame: 4-6 days after fertilization

    number of zygotes reaching the blastocyst stage of embryo development

  3. euploid rate

    Time frame: 1 week after trophectoderm biopsy

    number of chromosomally normal embryos

Sponsors and collaborators

Lead sponsor

Reproductive Medicine Associates of New Jersey

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 13, 2020
Registry last updated
Jan 14, 2022

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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