ARTNCT03343938
Evaluation of a Closed Assisted Reproductive Technology (ART) Station Versus an Open Flow Cabinet
A study testing Embryo handling in a closed station in people with ART, run by Vida Recoletas Sevilla at 1 site in Spain.
Trial summary
There is not yet a standardized system of human embryonic culture in vitro. In addition, technical improvements continually appear. The investigators recently carried out a study in which it shows that the grouped embryo culture at low oxygen tension (5% O2) in a benchtop incubator shows better success rates than… Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- ART
- What is being tested?
- Embryo handling in a closed station
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSpain
- Study dates
- 31 Oct 2017to 30 Nov 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 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signing a written consent to participate in the study.
- Blastocyst transfer:
- Patients using their own oocytes under 40 years.
- Patients using donated oocytes.
Who cannot join
- Preimplantation genetic screening patients.
- Severe male factor (spermatozoa of testicular or epididymal origin, patients with cryptozoospermia and patients with retrograde ejaculation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Two Systems of Gamete and Embryo Handling: Closed Environment Versus Open System
There is not yet a standardized system of human embryonic culture in vitro. In addition, technical improvements continually appear. The investigators recently carried out a study in which it shows that the grouped embryo culture at low oxygen tension (5% O2) in a benchtop incubator shows better success rates than individual culture at atmospheric oxygen tension (20% O2) in a conventional incubator. For these reasons, the investigators have decided to continue this research line to evaluate the efficacy of a new ART station with a closed environment in comparison of an open flow cabinet. This new system keeps a controled environment maintaining a carbon dioxide (CO2) concentration of 6% and a temperature of 37 degrees. A prospective randomized study will be carried out in which the manipulation of the gametes and pre-embryos of the patients will be carried out in open laminar flow cabinets or in a closed station that maintain the CO2 and temperature conditions.
- Conditions
- ART
- Being tested
- Embryo handling in a closed station
- Keywords
- Group embryo culture, Low oxygen tension, Closed station, Embryo handling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embryo handling in a closed stationOther
Embryo handling is performed inside a closed station with a controlled environment: 6% CO2 and 37 degrees.
| Study group | Role | What they receive |
|---|---|---|
| Closed Station | Experimental | Embryo handling is performed inside a closed station with a controlled environment: 6% CO2 and 37 degrees. Receives: Other: Embryo handling in a closed station |
| Open flow cabinet | No intervention | Embryo handling is performed inside a conventional open flow cabinet without a controlled environment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryo quality
Rate of viable embryos = Transferred and Frozen embryos / Total number of embryos obtained
Measured: Through study completion, an average of two years
Secondary outcomes (4)
Live birth rate per first embryo transfer
Total number of live births over the total of recruited patients (taking into account only the first cycle)
Measured: Through study completion, an average of two years
Cumulative live birth rate
Total number of live births over the total of recruited patients (taking into account fresh and cryopreserved cycles)
Measured: Through study completion, an average of two years
Implantation rate
Total of implanted embryos / total of transferred embryos
Measured: Through study completion, an average of two years
Live birth rate of the first cycle per transferred embryo
Total number of live births over the total of transferred embryo
Measured: Through study completion, an average of two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start31 Oct 2017
- Primary completion31 Oct 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARTStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vida Recoletas Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343938
- Sponsor's protocol ID
- 1605-SEV-036-NP
- Status last verified
- Feb 2020
- First submitted
- 31 Oct 2017
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Two Systems of Gamete and Embryo Handling: Closed Environment Versus Open System
- ClinicalTrials.gov ID
- NCT03343938
- Acronym / sponsor ID
- 1605-SEV-036-NP
- Conditions
- ART
- Keywords
- Group embryo culture, Low oxygen tension, Closed station, Embryo handling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Vida Recoletas SevillaUniversity, hospital or other
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 17 Nov 2017 (actual)
- 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.
There is not yet a standardized system of human embryonic culture in vitro. In addition, technical improvements continually appear. The investigators recently carried out a study in which it shows that the grouped embryo culture at low oxygen tension (5% O2) in a benchtop incubator shows better success rates than individual culture at atmospheric oxygen tension (20% O2) in a conventional incubator. For these reasons, the investigators have decided to continue this research line to evaluate the efficacy of a new ART station with a closed environment in comparison of an open flow cabinet. This new system keeps a controled environment maintaining a carbon dioxide (CO2) concentration of 6% and a temperature of 37 degrees. A prospective randomized study will be carried out in which the manipulation of the gametes and pre-embryos of the patients will be carried out in open laminar flow cabinets or in a closed station that maintain the CO2 and temperature conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed Station | Experimental | Other: Embryo handling in a closed stationEmbryo handling is performed inside a closed station with a controlled environment: 6% CO2 and 37 degrees. |
| Open flow cabinet | No intervention | –Embryo handling is performed inside a conventional open flow cabinet without a controlled environment. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signing a written consent to participate in the study.
- Blastocyst transfer:
- Patients using their own oocytes under 40 years.
- Patients using donated oocytes.
Key exclusion criteria (2 listed)
- Preimplantation genetic screening patients.
- Severe male factor (spermatozoa of testicular or epididymal origin, patients with cryptozoospermia and patients with retrograde ejaculation)
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 |
|---|---|---|
| Embryo handling in a closed stationEmbryo handling is performed inside a closed station with a controlled environment: 6% CO2 and 37 degrees. | Other | Closed Station |
Primary outcome
Embryo quality
Time frame: Through study completion, an average of two years
Rate of viable embryos = Transferred and Frozen embryos / Total number of embryos obtained
4 secondary outcomes
Live birth rate per first embryo transfer
Time frame: Through study completion, an average of two years
Cumulative live birth rate
Time frame: Through study completion, an average of two years
Implantation rate
Time frame: Through study completion, an average of two years
Live birth rate of the first cycle per transferred embryo
Time frame: Through study completion, an average of two years
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 12 Feb 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embryo handling in a closed station in people with ART, run by Vida Recoletas Sevilla 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 4 inclusion and 2 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 12 Feb 2020. 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?
Embryo quality (time frame: Through study completion, an average of two years). 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 12 Feb 2020.