Use of a Synthetic Macromolecule (Hydroxypropyl Cellulose ) and Trehalose as Additives for Oocyte Vitrification

Study Overview
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Brief Summary
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This study is aimed to evaluate the use of Hydroxypropyl Cellulose (HPC) as substitute for the traditional protein supplement (Synthetic Serum Substitute; SSS) and Trehalose as substitute for the most widely used sugar (Sucrose) in the vitrification solutions employed for oocyte vitrification.

Detailed Description
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Vitrification involves the transformation of an aqueous solution into a very viscous solid avoiding ice formation. To achieve this, the vitrification protocols include high concentrations of cryoprotectants dissolved in a base medium supplemented with serum rich in protein. Traditionally available preparations contains human albumin (HSA). The most commonly used in vitrification solutions is the synthetic serum replacement (SSS) consisting of synthetic glycoporoteins and HSA. The replacement of human albumin by other fully synthetic components enables compliance with the European directives for classification of Class III medical device in accordance with the Manual for the Classification of Medical Devices in the regulatory framework of the European community, and therefore these media have the European CE conformity marking (Directive 93/42/EEC). According to European regulations, Class III medical devices are subject to special supervision and require certification exam or design type examination by a notified body. Commercial media supplied by Kitazato supplies ® (Tokyo, Japan) to be used in this study have been submitted to the whole process of evaluation and certification by the notified body BSI0086. Because of physical properties of hydroxypropyl cellulose (HPC), fully synthetic macromolecule, including the ability to form a viscous gel at low temperatures, this macromolecule has been proposed as a substitute for human origin albumin (HSA). Another necessary component of vitrification media is sucrose, which acts as an osmotic agent. Trehalose, a disaccharide present in nature is used by certain species to survive extreme conditions, being able to remain vitrified for years. This sugar has also been employed previously in cryobiology in some vitrification protocols. We have tested HPC and threhalose for oocytes vitrification in a pilot study, showing that no impairment in the survival rates, embryo development and pregnancy rates. The current study is a prospective randomized trial aimed to assess the outcome of ovum donation cycles conducted with vitrified oocytes using HPC and trehalose versus oocytes vitrified using traditional available solutions containing HAS and sucrose.

Official Title
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Impact of Using Hydroxypropyl Cellulose (HPC) and Trehalose for Oocyte Vitrification in an Ovum Donation Program

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Synthetic macromolecule HPC and trehalose
* Procedure: SSS containing HSA and sucrose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Donors: < 35 years old Normal physical and gynecological examinations No family history of hereditary or chromosomal diseases. Normal karyotype Negative screening for sexually transmitted diseases. Oocyte recipients: Oocyte recipients < 50 years old Body mass index< 30 < 2 previous IVF failures No severe male factor No recurrent miscarriage No hidrosalpinx No myoma No adenomyosis No AMH alterations Exclusion Criteria: Donors and recipients not meeting inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitrified oocytes using HPC+Trehalose<br>Oocytes are vitrified using the synthetic macromolecule HPC and trehalose | Procedure: Synthetic macromolecule HPC and trehalose<br>* Oocytes are vitrified using the synthetic macromolecule HPC and trehalose<br>|
| Active Comparator: Vitrified oocytes using SSS+ Sucrose<br>Oocytes are vitrified using the SSS containing HSA and sucrose | Procedure: SSS containing HSA and sucrose<br>* • Oocytes are vitrified using the SSS containing HSA and sucrose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival after oocyte vitrification using cryoprotective solutions containing hiroxipropilcelulosa (HPC) and trehalose. | After warming and embryo transfer. Survival will be evaluated morphologically two hours after warming. | >2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embryo development |  | From time of thawing until pregnancy outcome (0-9 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oocyte vitrification, survival rate, egg banking, ovum donation