Use of a Synthetic Macromolecule (Hydroxypropyl Cellulose ) and Trehalose as Additives for Oocyte Vitrification
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

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.
    

Intervention name(s): Synthetic macromolecule HPC and trehalose; SSS containing HSA and sucrose
Intervention type(s): Procedure; Procedure
Intervention description(s): Oocytes are vitrified using the synthetic macromolecule HPC and trehalose; • Oocytes are vitrified using the SSS containing HSA and sucrose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Oocyte vitrification; survival rate; egg banking; ovum donation