Oocyte Cryopreservation by Slow Freezing and Vitrification

Study Overview
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Brief Summary
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This study seeks to evaluate whether the vitrification technique, as compared to the more traditional slow-cooling technique, leads to higher rates of successful thawing, fertilization, implantation and delivery.

Detailed Description
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Cryopreservation (freezing) of human gametes (unfertilized egg) provides a great potential to preserve or extend fertility in the face of disease and social circumstances (cancer diagnosis, delaying childbirth, single women, etc.). There are two methods for storage of oocytes (unfertilized eggs): slow freezing or vitrification (uses higher concentrations of cryoprotectant and faster cooling rates). Slow freezing is the standard method and has been successful for embryos since 1983 and more recently for oocytes. Recent reports indicate that vitrification may be more successful than slow freezing. The aim of this study is to examine the rate at which frozen eggs survive freezing and thawing, the rate at which the frozen/thawed eggs fertilize with sperm and the pregnancy outcomes of oocyte (egg) vitrification cycles to determine whether the outcomes are similar or better than standard oocyte (egg) cryopreservation (freezing) cycles.

Official Title
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Longitudinal Evaluation of Vitrification of Human Oocytes

Conditions
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Women Diagnosed With Cancer, Egg Donors, Single Women, Failed Sperm Procurement in IVF

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: Age between 21 and 50 years, at the time of informed consent. Subjects must agree to undergo intracytoplasmic sperm injection (ICSI) Exclusion Criteria: Presence of any medical condition that contraindicates ovarian stimulation, in vitro fertilization or pregnancy.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Slow Freezing<br>oocytes will be frozen by slow freeze/ rapid thaw | Procedure: slow freeze<br>* Eggs will be placed in a cryo-protected solution and frozen slowly in a programable freezer<br>* Other names: slow freezing;|
| Experimental: Vitrification<br>oocytes will be frozen using rapid freezing/rapid thaw | Procedure: Vitrification<br>* Eggs will be placed in a high concentration of cryo-protectant and frozen very quickly by plunging in liquid nitrogen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oocytes survival after thaw | Whether each oocyte survives the thawing process | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization | Whether each oocyte is successfully fertilized | 1 month | 
| Implantation | Whether pregnancy occurs. | 1 month | 

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