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

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Procedure: SSS containing HSA and sucrose; Procedure: Synthetic macromolecule HPC and trehalose

• Registration Number: NCT01745523
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-29
• Study First Submitted QC: 2012-12-07
• Study First Posted: 2012-12-10
• Primary Completion: 2014-04
• Study Completion: 2014-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-09
• Last Update Posted: 2015-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 440

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitrified oocytes using SSS+ Sucrose	SSS containing HSA and sucrose	Oocytes are vitrified using the SSS containing HSA and sucrose
Vitrified oocytes using HPC+Trehalose	Synthetic macromolecule HPC and trehalose	Oocytes are vitrified using the synthetic macromolecule HPC and trehalose

Primary Outcome Measures

Name	Time	Method
Survival after oocyte vitrification using cryoprotective solutions containing hiroxipropilcelulosa (HPC) and trehalose.	>2 hours	After warming and embryo transfer. Survival will be evaluated morphologically two hours after warming.

Secondary Outcome Measures

Name	Time	Method
Embryo development	From time of thawing until pregnancy outcome (0-9 months)

Trial Locations

Locations (1)

IVI Valencia; 🇪🇸 Valencia, Spain