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

This study has been completed.
Information provided by (Responsible Party):
Ana Cobo, Instituto Valenciano de Infertilidad, IVI VALENCIA Identifier:
First received: November 29, 2012
Last updated: March 9, 2015
Last verified: March 2015
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 Intervention
Procedure: Synthetic macromolecule HPC and trehalose
Procedure: SSS containing HSA and sucrose

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: "Impact of Using Hydroxypropyl Cellulose (HPC) and Trehalose for Oocyte Vitrification in an Ovum Donation Program"

Resource links provided by NLM:

Further study details as provided by Ana Cobo, Instituto Valenciano de Infertilidad, IVI VALENCIA:

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

Enrollment: 440
Study Start Date: November 2012
Study Completion Date: October 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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

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Please refer to this study by its identifier: NCT01745523

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

Responsible Party: Ana Cobo, Cryobiology Unit Director at IVI Valencia, Instituto Valenciano de Infertilidad, IVI VALENCIA Identifier: NCT01745523     History of Changes
Other Study ID Numbers: 1206-C-103-AC ( Registry Identifier: )
Study First Received: November 29, 2012
Last Updated: March 9, 2015

Keywords provided by Ana Cobo, Instituto Valenciano de Infertilidad, IVI VALENCIA:
Oocyte vitrification
survival rate
egg banking
ovum donation

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on May 25, 2017