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"
2 other identifiers
interventional
440
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 29, 2012
CompletedFirst Posted
Study publicly available on registry
December 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedMarch 10, 2015
March 1, 2015
1.4 years
November 29, 2012
March 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Embryo development
From time of thawing until pregnancy outcome (0-9 months)
Study Arms (2)
Vitrified oocytes using HPC+Trehalose
EXPERIMENTALOocytes are vitrified using the synthetic macromolecule HPC and trehalose
Vitrified oocytes using SSS+ Sucrose
ACTIVE COMPARATOROocytes are vitrified using the SSS containing HSA and sucrose
Interventions
Oocytes are vitrified using the synthetic macromolecule HPC and trehalose
• Oocytes are vitrified using the SSS containing HSA and sucrose
Eligibility Criteria
You may qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IVI Valencia
Valencia, 46117, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ana Cobo, PhD
IVI Valencia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cryobiology Unit Director at IVI Valencia
Study Record Dates
First Submitted
November 29, 2012
First Posted
December 10, 2012
Study Start
November 1, 2012
Primary Completion
April 1, 2014
Study Completion
October 1, 2014
Last Updated
March 10, 2015
Record last verified: 2015-03