InfertilityNCT01745523
Use of a Synthetic Macromolecule (Hydroxypropyl Cellulose ) and Trehalose as Additives for Oocyte Vitrification
A study testing Synthetic macromolecule HPC and trehalose and SSS containing HSA and sucrose in people with Infertility, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Synthetic macromolecule HPC and trehalose and SSS containing HSA and sucrose
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- Donors and recipients not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Synthetic macromolecule HPC and trehalose, SSS containing HSA and sucrose
- Keywords
- Oocyte vitrification, survival rate, egg banking, ovum donation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synthetic macromolecule HPC and trehaloseProcedure or surgery
Oocytes are vitrified using the synthetic macromolecule HPC and trehalose
SSS containing HSA and sucroseProcedure or surgery
- Oocytes are vitrified using the SSS containing HSA and sucrose
| Study group | Role | What they receive |
|---|---|---|
| Vitrified oocytes using HPC+Trehalose | Experimental | Oocytes are vitrified using the synthetic macromolecule HPC and trehalose Receives: Procedure: Synthetic macromolecule HPC and trehalose |
| Vitrified oocytes using SSS+ Sucrose | Active comparator | Oocytes are vitrified using the SSS containing HSA and sucrose Receives: Procedure: SSS containing HSA and sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: >2 hours
Secondary outcomes (1)
Embryo development
Measured: From time of thawing until pregnancy outcome (0-9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Cobo, Instituto Valenciano de Infertilidad, IVI VALENCIA
- Investigators
- Ana Cobo, PhD, Principal investigator, IVI Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745523
- Sponsor's protocol ID
- 1206-C-103-AC
- Other IDs
- ClinicalTrials.gov
- Status last verified
- Mar 2015
- First submitted
- 29 Nov 2012
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Impact of Using Hydroxypropyl Cellulose (HPC) and Trehalose for Oocyte Vitrification in an Ovum Donation Program"
- ClinicalTrials.gov ID
- NCT01745523
- Acronym / sponsor ID
- 1206-C-103-AC
- Conditions
- Infertility
- Keywords
- Oocyte vitrification, survival rate, egg banking, ovum donation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitrified oocytes using HPC+Trehalose | Experimental | Procedure: Synthetic macromolecule HPC and trehaloseOocytes are vitrified using the synthetic macromolecule HPC and trehalose |
| Vitrified oocytes using SSS+ Sucrose | Active comparator | Procedure: SSS containing HSA and sucroseOocytes are vitrified using the SSS containing HSA and sucrose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- < 35 years old
- Normal physical and gynecological examinations
- No family history of hereditary or chromosomal diseases.
- Normal karyotype
- Negative screening for sexually transmitted diseases.
Key exclusion criteria (1 listed)
- Donors and recipients not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synthetic macromolecule HPC and trehaloseOocytes are vitrified using the synthetic macromolecule HPC and trehalose | Procedure or surgery | Vitrified oocytes using HPC+Trehalose |
| SSS containing HSA and sucrose• Oocytes are vitrified using the SSS containing HSA and sucrose | Procedure or surgery | Vitrified oocytes using SSS+ Sucrose |
Primary outcome
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.
1 secondary outcome
Embryo development
Time frame: From time of thawing until pregnancy outcome (0-9 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Cobo, PhD principal investigator
IVI Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synthetic macromolecule HPC and trehalose and SSS containing HSA and sucrose in people with Infertility, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival after oocyte vitrification using cryoprotective solutions containing hiroxipropilcelulosa (HPC) and trehalose. (time frame: >2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.