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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01745523
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : March 10, 2015
Information provided by (Responsible Party):
Ana Cobo, 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.

Condition or disease Intervention/treatment Phase
Infertility Procedure: Synthetic macromolecule HPC and trehalose Procedure: SSS containing HSA and sucrose Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: "Impact of Using Hydroxypropyl Cellulose (HPC) and Trehalose for Oocyte Vitrification in an Ovum Donation Program"
Study Start Date : November 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Vitrified oocytes using HPC+Trehalose
Oocytes are vitrified using the synthetic macromolecule HPC and trehalose
Procedure: Synthetic macromolecule HPC and trehalose
Oocytes are vitrified using the synthetic macromolecule HPC and trehalose

Active Comparator: Vitrified oocytes using SSS+ Sucrose
Oocytes are vitrified using the SSS containing HSA and sucrose
Procedure: SSS containing HSA and sucrose
• Oocytes are vitrified using the SSS containing HSA and sucrose

Primary Outcome Measures :
  1. Survival after oocyte vitrification using cryoprotective solutions containing hiroxipropilcelulosa (HPC) and trehalose. [ Time Frame: >2 hours ]
    After warming and embryo transfer. Survival will be evaluated morphologically two hours after warming.

Secondary Outcome Measures :
  1. Embryo development [ Time Frame: From time of thawing until pregnancy outcome (0-9 months) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:


  • < 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01745523

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IVI Valencia
Valencia, Spain, 46117
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
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Principal Investigator: Ana Cobo, PhD IVI Valencia

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Responsible Party: Ana Cobo, Cryobiology Unit Director at IVI Valencia, Instituto Valenciano de Infertilidad, IVI VALENCIA Identifier: NCT01745523    
Other Study ID Numbers: 1206-C-103-AC ( Registry Identifier: )
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 2015
Keywords provided by Ana Cobo, Instituto Valenciano de Infertilidad, IVI VALENCIA:
Oocyte vitrification
survival rate
egg banking
ovum donation
Additional relevant MeSH terms:
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Genital Diseases, Male
Genital Diseases, Female
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents