Clinical trial NCT01745523: Use of a Synthetic Macromolecule (Hydroxypropyl Cellulose ) and Trehalose as Additives for Oocyte Vitrification
Official title: "Impact of Using Hydroxypropyl Cellulose (HPC) and Trehalose for Oocyte Vitrification in an Ovum Donation Program"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Oocyte vitrification
survival rate
egg banking
ovum donation
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2012-12-10
Enrollment: 440
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival after oocyte vitrification using cryoprotective solutions containing hiroxipropilcelulosa (HPC) and trehalose.
timeFrame: >2 hours
Secondary outcomes:
measure: Embryo development
timeFrame: From time of thawing until pregnancy outcome (0-9 months)
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
affiliation: IVI Valencia
name: Ana Cobo, PhD
role: PRINCIPAL_INVESTIGATOR
References: