Embryo TransferEmbryoTempNCT02650310
New Device to Maintain the Embryo Temperature During Transfer
A study testing Thermostable device in people with Embryo Transfer, run by Rafael Bernabeu Pérez at 1 site in Spain.
Trial summary
The embryo transfer implies transportation from the incubator where they have been at 37 ° C, to the transfer catheter inside a laminar flow hood whose working surface is also maintained at 37 ° C. . Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Embryo Transfer
- What is being tested?
- Thermostable device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2015to Dec 2019
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cryo-transfer cycles: transfer of embryos vitrified in previous cycles receiving donated eggs inseminated with either conjugal or donated sperm from Instituto Bernabeu bank.
Who cannot join
- Fresh cycles: transfer of fresh embryos (coming from donated or own eggs), and cryo-transfer cycles from vitrified embryos coming from own oocytes.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Instituto Bernabeu
Alicante, 03016
Rafael Bernabeu, M.D., Ph.D., +34965154000, rbernabeu@institutobernabeu.com
Rafael Bernabeu, M.D., Ph.D, +34965154000, rbernabeu@institutobernabeu.com
About this study
Official title: A New System for Preventing Thermal Stress During Embryo Transfer
The embryo transfer implies transportation from the incubator where they have been at 37 ° C, to the transfer catheter inside a laminar flow hood whose working surface is also maintained at 37 ° C. . From the laboratory to the operating room the embryo is exposed to a temperature drop, and consequently thermal stress occurs, which may compromise its future viability.
The aim of this study is to assess the possible improvement in the clinical results when the embryos are transported in a stable device to avoid the drop in temperature throughout the transfer process.
With the use of this thermosetting device heated to 37 ° C, researchers expect a 15% increase in pregnancy rates.
- Conditions
- Embryo Transfer
- Being tested
- Thermostable device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermostable deviceDevice
Investigators place the catheter with the loaded embryos into a plastic device at 37ºC in order to maintain the temperature
| Study group | Role | What they receive |
|---|---|---|
| Conventional transfer | No intervention | This arm is the control group (conventional embryo transfer protocol) where there is no intervention. |
| Thermostable device transfer | Experimental | This arm is the study group: embryo transfer protocol using a new thermostable device. Receives: Device: Thermostable device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing Pregnancy rate
Achieving an ongoing pregnancy after embryo transfer
Measured: Ongoing pregnancy until 28th week of gestation
Secondary outcomes (2)
Miscarriage rate
To know the embryonic loss rate after implantation
Measured: Loss of pregnancy up to 12 weeks of gestation
Implantation rate
To know the embryo implantation rate after the embryo transfer
Measured: Embryo implantation after 6-7 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startApr 2015
- Primary completionMar 2019
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryo TransferStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rafael Bernabeu Pérez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rafael Bernabeu Pérez, Instituto Bernabeu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650310
- Sponsor's protocol ID
- Instituto Bernabeu Group
- Acronym
- EmbryoTemp
- Status last verified
- Aug 2019
- First submitted
- 28 Sep 2015
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New System for Preventing Thermal Stress During Embryo Transfer
- ClinicalTrials.gov ID
- NCT02650310
- Acronym / sponsor ID
- EmbryoTemp / Instituto Bernabeu Group
- Conditions
- Embryo Transfer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- Rafael Bernabeu PérezUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Mar 2019 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 8 Jan 2016 (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.
The embryo transfer implies transportation from the incubator where they have been at 37 ° C, to the transfer catheter inside a laminar flow hood whose working surface is also maintained at 37 ° C. . From the laboratory to the operating room the embryo is exposed to a temperature drop, and consequently thermal stress occurs, which may compromise its future viability.
The aim of this study is to assess the possible improvement in the clinical results when the embryos are transported in a stable device to avoid the drop in temperature throughout the transfer process.
With the use of this thermosetting device heated to 37 ° C, researchers expect a 15% increase in pregnancy rates.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional transfer | No intervention | –This arm is the control group (conventional embryo transfer protocol) where there is no intervention. |
| Thermostable device transfer | Experimental | Device: Thermostable deviceThis arm is the study group: embryo transfer protocol using a new thermostable device. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Cryo-transfer cycles: transfer of embryos vitrified in previous cycles receiving donated eggs inseminated with either conjugal or donated sperm from Instituto Bernabeu bank.
Key exclusion criteria (1 listed)
- Fresh cycles: transfer of fresh embryos (coming from donated or own eggs), and cryo-transfer cycles from vitrified embryos coming from own oocytes.
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 |
|---|---|---|
| Thermostable deviceInvestigators place the catheter with the loaded embryos into a plastic device at 37ºC in order to maintain the temperature | Device | Thermostable device transfer |
Primary outcome
Ongoing Pregnancy rate
Time frame: Ongoing pregnancy until 28th week of gestation
Achieving an ongoing pregnancy after embryo transfer
2 secondary outcomes
Miscarriage rate
Time frame: Loss of pregnancy up to 12 weeks of gestation
Implantation rate
Time frame: Embryo implantation after 6-7 weeks of gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermostable device in people with Embryo Transfer, run by Rafael Bernabeu Pérez 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 1 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: status not confirmed, as of the sponsor's last update on 9 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Ten Morro, Ph.D. (696914882, jten@institutobernabeu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing Pregnancy rate (time frame: Ongoing pregnancy until 28th week of gestation). 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 9 Aug 2019.