Temperature; Extreme, ExposureNCT03548532
Embryo Culture At a Constant Temperature of 36.6°C or 37.1°C
A study testing G210 incubator in people with Temperature; Extreme, Exposure, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
On the day of oocyte retrieval, participants will be randomized to stable culture at 37.1°C or 36.6°C with the ultimate aim of finding a difference in clincial pregnancies. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Temperature; Extreme, Exposure
- What is being tested?
- G210 incubator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2017to 18 Jan 2023
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Day 5 transfer
- Single embryo transfer
- Only ejaculated sperm (fresh or frozen, autologous or heterologous)
- BMI <35
- Age <40 years
- Cycle rank <3 for the current child
- Last ultrasound: 8 follicles of at least 12 mm
- At least 6 mature oocytes
Who cannot join
- IVF
- IVF versus ICSI
- Failed fertilization in previous cycle
- no previous cycle without embryo transfer
- No use of Ca ionophores for embryo quality or fertilization problems
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Universitair Ziekenhuis Brussel
Brussels, Brussels Capital, 1090
About this study
Official title: Embryo Culture At a Constant Temperature of 36.6°C or 37.1°C: a Randomized Controlled Trial
On the day of oocyte retrieval, participants will be randomized to stable culture at 37.1°C or 36.6°C with the ultimate aim of finding a difference in clincial pregnancies.
Read the detailed description
A previous study in our centre analysed stable embryo culture at 36.6°C and 37.1°C, on sibling oocytes. The primary aim was to analyse possible differneces in embryo development (utilization rate) up to day 5/6. In this study, the investigators found a high difference in clinical pregnancy rate between both groups (46.4% versus 77.4%). Since this study was not powered to find differences in clincial pregnancy rates between both groups, this RCT was especially powered as a superiority trial to find differences in clincial pregnancy rates between both groups. On the day of oocyte retrieval, patients will be allocated to culture at one of both temperatures.
- Conditions
- Temperature; Extreme, Exposure
- Being tested
- G210 incubator
- Keywords
- temperature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G210 incubatorDevice
Also called Ksystems
very stable culture temperature, up to 0.1°C, in both arms
| Study group | Role | What they receive |
|---|---|---|
| 36.6°C | Active comparator | Embryos of these patients will be cultured at 36.6°C from day 0 after ICSI, untill day 6. Receives: Device: G210 incubator |
| 37.1°C | Experimental | Embryos of these patients will be cultured at 37.1°C from day 0 after ICSI, untill day 6. Receives: Device: G210 incubator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy
ultrasound: sac and fetal heartbeat positive
Measured: 7 weeks
Secondary outcomes (4)
Fertilization rate
number of fertilized oocytes, per number of injected oocytes
Measured: 1 day
embryo development/utilization rate
number of embryos transferred or cryopreserved per fertilized oocytes
Measured: 6 days
live birth rate of the fresh cycle
number of live births per started cycle
Measured: 43 weeks
cumulative live birth rate per cycle
fresh and frozen embryo transfer: outcome of the deliveries
Measured: 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start1 Nov 2017
- Primary completion26 Nov 2022
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temperature; Extreme, ExposureStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Based on the randomisation list, patients fulfilling the inclusion criteria will be assigned to one of each arm. A total of 119 patients are needed in every arm in this superiority trial.
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neelke De Munck, Universitair Ziekenhuis Brussel
- Investigators
- Greta Verheyen, PhD, Study director, UZBrussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548532
- Sponsor's protocol ID
- 2017/060
- Status last verified
- Jan 2023
- First submitted
- 23 Oct 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For statistical Analysis
Publications
Wouters K, Mateizel I, Segers I, Van de Velde H, Van Landuyt L, De Vos A, Schoemans C, Jankovic D, Blockeel C, Drakopoulos P, Tournaye H, De Munck N. Clinical pregnancy rates after blastocyst culture at a stable temperature of 36.6 degrees C versus 37.1 degrees C: a prospective randomized controlled trial. Hum Reprod. 2024 Oct 1;39(10):2233-2239. doi: 10.1093/humrep/deae193.
PubMed 39241807
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embryo Culture At a Constant Temperature of 36.6°C or 37.1°C: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03548532
- Acronym / sponsor ID
- 2017/060
- Conditions
- Temperature; Extreme, Exposure
- Keywords
- temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 26 Nov 2022 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 7 Jun 2018 (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.
On the day of oocyte retrieval, participants will be randomized to stable culture at 37.1°C or 36.6°C with the ultimate aim of finding a difference in clincial pregnancies.
Detailed description
A previous study in our centre analysed stable embryo culture at 36.6°C and 37.1°C, on sibling oocytes. The primary aim was to analyse possible differneces in embryo development (utilization rate) up to day 5/6. In this study, the investigators found a high difference in clinical pregnancy rate between both groups (46.4% versus 77.4%). Since this study was not powered to find differences in clincial pregnancy rates between both groups, this RCT was especially powered as a superiority trial to find differences in clincial pregnancy rates between both groups. On the day of oocyte retrieval, patients will be allocated to culture at one of both temperatures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Based on the randomisation list, patients fulfilling the inclusion criteria will be assigned to one of each arm. A total of 119 patients are needed in every arm in this superiority trial.
| Arm | Type | Receives |
|---|---|---|
| 36.6°C | Active comparator | Device: G210 incubatorEmbryos of these patients will be cultured at 36.6°C from day 0 after ICSI, untill day 6. |
| 37.1°C | Experimental | Device: G210 incubatorEmbryos of these patients will be cultured at 37.1°C from day 0 after ICSI, untill day 6. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Day 5 transfer
- Single embryo transfer
- Only ejaculated sperm (fresh or frozen, autologous or heterologous)
- BMI <35
- Age <40 years
Key exclusion criteria (5 listed)
- IVF
- IVF versus ICSI
- Failed fertilization in previous cycle
- no previous cycle without embryo transfer
- No use of Ca ionophores for embryo quality or fertilization problems
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 |
|---|---|---|
| G210 incubatorAlso: Ksystemsvery stable culture temperature, up to 0.1°C, in both arms | Device | 36.6°C, 37.1°C |
Primary outcome
Clinical pregnancy
Time frame: 7 weeks
ultrasound: sac and fetal heartbeat positive
4 secondary outcomes
Fertilization rate
Time frame: 1 day
embryo development/utilization rate
Time frame: 6 days
live birth rate of the fresh cycle
Time frame: 43 weeks
cumulative live birth rate per cycle
Time frame: 104 weeks
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 19 Sep 2024.
- Derived from this study: PubMed 39241807Wouters K, Mateizel I, Segers I, Van de Velde H, Van Landuyt L, De Vos A, Schoemans C, Jankovic D, Blockeel C, Drakopoulos P, Tournaye H, De Munck N. Clinical pregnancy rates after blastocyst culture at a stable temperature of 36.6 degrees C versus 37.1 degrees C: a prospective randomized controlled trial. Hum Reprod. 2024 Oct 1;39(10):2233-2239. doi: 10.1093/humrep/deae193.
- Individual participant dataSharing planned: Yes. For statistical Analysis
Related trials for Temperature; Extreme, Exposure
Not yet recruiting
Indoor Overheating and Physiological Strain in Older Adults With COPD
Chronic Obstructive Pulmonary Disease (COPD), Heat Stress
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.
Greta Verheyen, PhD study director
UZBrussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G210 incubator in people with Temperature; Extreme, Exposure, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 8 inclusion and 5 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 19 Sep 2024. 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 Belgium. 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?
Clinical pregnancy (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03548532, which also lists 1 linked publication.
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 19 Sep 2024.