Randomized Controlled Trial Comparing Slow-freezing to Vitrification of Oocytes

Study Overview
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Brief Summary
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Preservation of fertility is limited. Current methods include embryo cryopreservation and while still experimental, ovarian cryopreservation. In single women who are at risk for infertility secondary to cancer or couples who have ethical reasons to avoid embryo cryopreservation, oocyte cryopreservation is an alternative Purpose of study is to compare slow freeze to vitrification of human oocytes. Successful cryopreservation and subsequent thawing programs are characterized by avoiding ice crystal formation.Vitrification, newer alternative to slow freeze method, process by which water is prevented from forming ice. Our hypothesis is that higher survival rate per oocyte is to be expected in the vitrification group.

Detailed Description
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Although several reviews of smaller studies of cryoprotectant methodology exist randomized controlled trials,comparing slow-freeze-rapid-thaw procedure to vitrification of oocytes, are not available. The purpose of this study is to compare these two methods of oocyte cryopreservation in human oocytes.

Official Title
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Cryopreservation of Oocytes: A Randomized Controlled Trial Comparing Slow-freezing to Vitrification

Conditions
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Infertility

Intervention / Treatment
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* Procedure: slow-freeze
* Procedure: vitrification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 14 or more oocytes at ovum pick up age < 38 bmi < 30 Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>slow-freeze | Procedure: slow-freeze<br>* Slow-freeze-rapid-thaw procedure of oocytes is characterized by prolonged exposure of the cell to cryoprotectants in a low metabolic state at very low temperatures<br>|
| Active Comparator: 2<br>vitrification | Procedure: vitrification<br>* Vitrification is the process by which water is prevented from forming ice due to the viscosity of a highly concentrated cryoprotectant cooled at an extremely rapid rate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-thaw oocyte survival rate |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fertilization rate |  | 2 years | 
| cleavage |  | 2 years | 
| embryo development |  | 2 years | 
| implantation rate |  | 2 years | 
| ongoing pregnancy |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human oocyte cryopreservation, slow-freeze, vitrification