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

"Impact of Using Hydroxypropyl Cellulose (HPC) and Trehalose for Oocyte Vitrification in an Ovum Donation Program"

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Procedure: Synthetic macromolecule HPC and trehalose; Procedure: 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.

• Study Type: Interventional
• Enrollment (Actual): 440
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46117
    • IVI Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Embryo development	From time of thawing until pregnancy outcome (0-9 months)

Collaborators and Investigators

• Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Investigators: Principal Investigator: Ana Cobo, PhD, IVI Valencia

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: November 29, 2012
• First Submitted That Met QC Criteria: December 7, 2012
• First Posted (ESTIMATE): December 10, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 10, 2015
• Last Update Submitted That Met QC Criteria: March 9, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: survival rate; Oocyte vitrification; egg banking; ovum donation
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 1206-C-103-AC; ClinicalTrials.gov (ClinicalTrials.gov)