InfertilityNCT01745536
Closed Vitrification of Oocytes
A study testing Oocytes are vitrified/stored using a closed device and Oocytes are vitrified/stored using an open device in people with Infertility, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 2 sites in Spain.
Trial summary
This study is aimed to evaluate the use of a closed device for storage of vitrified oocytes. 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?
- Oocytes are vitrified/stored using a closed device and Oocytes are vitrified/stored using an open device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesSpain
- Study dates
- Nov 2012to Oct 2015
- 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.
Show all 16Show fewer
- 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
2 sites in 1 country.
About this study
Official title: "Impact of a Closed System in Donor Oocyte Vitrification"
This study is aimed to evaluate the use of a closed device for storage of vitrified oocytes.
Read the detailed description
The Cryotop method for oocyte vitrification is classified as "open system", which means that it requires direct contact with liquid nitrogen during the vitrification process. The system has an external straw to protect the samples during storage, but the device is not hermetically sealed. Instead closed systems are devices that are hermetically sealed before vitrification and remain sealed during storage. Open systems have proven highly effective in achieving similar outcomes with vitrified oocytes compared to those achieved with fresh ones. On the contrary, closed systems have failed to be as effective as open ones when used for oocyte vitrification. Although open systems have proven to be highly efficient, where many other methods have failed, they have been related to a theoretical risk of contamination due to direct contact with liquid nitrogen. Though to date there have been no reported cases of transmission of disease after cryo-transfers either for slow freezing or vitrification, some European countries prohibit the use of open systems for vitrification. In this study, we will evaluate the results after the donor oocyte vitrification, using a modification of a current device (Cryotop®), which makes it capable of being hermetically sealed. The current study is a prospective randomized trial aimed to assess the outcome of ovum donation cycles conducted with vitrified oocytes using the closed device versus oocytes vitrified using the traditional open device.
- Conditions
- Infertility
- Being tested
- Oocytes are vitrified/stored using a closed device, Oocytes are vitrified/stored using an open device
- 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.
Oocytes are vitrified/stored using a closed deviceProcedure or surgery
Vitrification will be carried out using a modification of the current device (Cryotop®), thus providing air tight sealing. Closed systems are devices that are hermetically sealed before vitrification and remain sealed during storage.
Oocytes are vitrified/stored using an open deviceProcedure or surgery
The vitrification process takes place through direct contact with liquid nitrogen. The system has an external straw to protect the samples during storage, but the device is not hermetically sealed.
| Study group | Role | What they receive |
|---|---|---|
| Vitrified oocytes using closed Cryotop® | Experimental | Oocytes are vitrified/stored using a closed device Receives: Procedure: Oocytes are vitrified/stored using a closed device |
| Vitrified oocytes using open Cryotop® | Active comparator | Oocytes are vitrified/stored using an open device Receives: Procedure: Oocytes are vitrified/stored using an open device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival after oocyte vitrification using the closed device Cryotop®
Survival will be evaluated morphologically two hours after warming.
Measured: >2 hours
Secondary outcomes (1)
Embryo development
Measured: From thawing and 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 completionOct 2015
- Study completionOct 2015
Why it stopped: NO RECRUITMENT
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
- 0 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
- NCT01745536
- Sponsor's protocol ID
- 1206-C-104-AC
- Other IDs
- Clinical Trials.gov
- Status last verified
- Mar 2016
- First submitted
- 29 Nov 2012
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Impact of a Closed System in Donor Oocyte Vitrification"
- ClinicalTrials.gov ID
- NCT01745536
- Acronym / sponsor ID
- 1206-C-104-AC
- Conditions
- Infertility
- Keywords
- Oocyte vitrification, survival rate, egg banking, ovum donation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: NO RECRUITMENT
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (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 a closed device for storage of vitrified oocytes.
Detailed description
The Cryotop method for oocyte vitrification is classified as "open system", which means that it requires direct contact with liquid nitrogen during the vitrification process. The system has an external straw to protect the samples during storage, but the device is not hermetically sealed. Instead closed systems are devices that are hermetically sealed before vitrification and remain sealed during storage. Open systems have proven highly effective in achieving similar outcomes with vitrified oocytes compared to those achieved with fresh ones. On the contrary, closed systems have failed to be as effective as open ones when used for oocyte vitrification. Although open systems have proven to be highly efficient, where many other methods have failed, they have been related to a theoretical risk of contamination due to direct contact with liquid nitrogen. Though to date there have been no reported cases of transmission of disease after cryo-transfers either for slow freezing or vitrification, some European countries prohibit the use of open systems for vitrification. In this study, we will evaluate the results after the donor oocyte vitrification, using a modification of a current device (Cryotop®), which makes it capable of being hermetically sealed. The current study is a prospective randomized trial aimed to assess the outcome of ovum donation cycles conducted with vitrified oocytes using the closed device versus oocytes vitrified using the traditional open device.
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 closed Cryotop® | Experimental | Procedure: Oocytes are vitrified/stored using a closed deviceOocytes are vitrified/stored using a closed device |
| Vitrified oocytes using open Cryotop® | Active comparator | Procedure: Oocytes are vitrified/stored using an open deviceOocytes are vitrified/stored using an open device |
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 |
|---|---|---|
| Oocytes are vitrified/stored using a closed deviceVitrification will be carried out using a modification of the current device (Cryotop®), thus providing air tight sealing. Closed systems are devices that are hermetically sealed before vitrification and remain sealed during storage. | Procedure or surgery | Vitrified oocytes using closed Cryotop® |
| Oocytes are vitrified/stored using an open deviceThe vitrification process takes place through direct contact with liquid nitrogen. The system has an external straw to protect the samples during storage, but the device is not hermetically sealed. | Procedure or surgery | Vitrified oocytes using open Cryotop® |
Primary outcome
Survival after oocyte vitrification using the closed device Cryotop®
Time frame: >2 hours
Survival will be evaluated morphologically two hours after warming.
1 secondary outcome
Embryo development
Time frame: From thawing and until pregnancy outcome (0-9 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oocytes are vitrified/stored using a closed device and Oocytes are vitrified/stored using an open device in people with Infertility, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 2 sites 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: withdrawn, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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 the closed device Cryotop® (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 8 Mar 2016.