Oocyte Survival After Vitrification With Slush Nitrogen Compared With Liquid Nitrogen

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-08

Study Completion Date

2021-07-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial in a paired design

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

embryologist assessing oocyte survival (primary outcome) is blinded

Study Groups

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Slush nitrogen

oocytes are randomized to undergo vitrification utilizing slush nitrogen

Group Type ACTIVE_COMPARATOR

Vitrification via slush nitrogen

Intervention Type OTHER

oocytes will be vitrified using slush nitrogen

Liquid Nitrogen

oocytes are randomized to undergo vitrification utilizing liquid nitrogen which is the current standard of care

Group Type ACTIVE_COMPARATOR

Vitrification via liquid nitrogen

Intervention Type OTHER

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

Interventions

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Vitrification via slush nitrogen

oocytes will be vitrified using slush nitrogen

Intervention Type OTHER

Vitrification via liquid nitrogen

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age 30 years or younger who meet institutional criteria to be an oocyte donor.
2. Patients who agree to donate oocytes for research purposes and agree to the study protocol.
3. 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.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No