Culture MediaNCT02971878
Comparisons of Human Embryonic Development Using Single Medium With and Without the Addition of Antioxidants
A study testing Acetyl-L-carnitine (ALC), N-acetyl-L-cysteine (NAC) and α-lipoic acid (ALA) in people with Culture Media and Blastocyst, run by Fertilitetscentrum AB at 1 site in Sweden.
Trial summary
Aim: To investigate the impact of antioxidants (acetyl-L-carnitine, N-acetyl-L-cysteine and a-lipoic acid) on embryo development and subsequently the clinical outcome. Including clinics using low oxygen and ambient air during embryo culture. Analysed with time-lapse system. Study media: G-TL with antioxidants. Read more about this study
- Who is it for?
- Ages 20 to 41 years
- Conditions the study is for
- Culture Media, Blastocyst, Antioxidants
- What is being tested?
- Acetyl-L-carnitine (ALC), N-acetyl-L-cysteine (NAC) and α-lipoic acid (ALA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2016to 1 Feb 2018
- 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 20 to 41 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Couples with female, male or unexplained infertility intending to undergo IVF
- The couple should have received verbal and written information/consent about the study.
- 6 or more fertilized oocytes on day 1
- Blastocyst culture and transfer on day 5
- Signed written consent
Who cannot join
- Previous participation in the study.
- Testicular biopsy patients (TESA/TESE)
- Fewer than 6 fertilized oocytes.
- If split IVF is needed.
- Total freeze on day 3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adding Antioxidants Into Human Embryo Culture Media
Aim: To investigate the impact of antioxidants (acetyl-L-carnitine, N-acetyl-L-cysteine and a-lipoic acid) on embryo development and subsequently the clinical outcome. Including clinics using low oxygen and ambient air during embryo culture. Analysed with time-lapse system.
Study media: G-TL with antioxidants. Control media: Same media without antioxidants. Type of study: Study comparing blastocyst development on the same cohort of oocytes using two different media, G-TL versus G-TL supplemented with antioxidants. Statistics based on an absolute increase in Good Quality Blastocysts on day 5 of 7%.
Read more
Design: Multicentre prospective randomized sibling trial. Single blastocyst transfer. Superiority study Primary Endpoint: Good Quality Blastocysts on day 5 per allocated normally fertilized oocyte.
Patients: Comparative embryo sibling study with 128 patients included.
Read the detailed description
Study objective: Study comparing blastocyst development on the same cohort of oocytes using two different media, G-TL versus G-TL supplemented with antioxidants.
Primary endpoint: Percentage of good quality blastocysts (GQB) per fertilized oocyte on day 5.
Secondary endpoints
- Embryo development day 3, 5 and 6
- Embryo quality day 3, 5 and 6
- Total blastocyst formation (day 5 and day 6)
- Utilization rate (embryos available for transfer and cryopreservation)
- Implantation rate
- Clinical pregnancy rate
Setup: Prospective embryo sibling, superiority study
MATERIALS AND METHODS Intervention New type of embryo culture media used for in vitro culture of human IVF embryos.
Power analysis The planning and the power analysis was made together with a statistician, Nils-Gunnar Pehrsson.
From retrospective data using simulation, the intra individual SD for the difference in % GQB between the two media strategies was estimated to 32%. In order to find a difference in 8% in GQB between the two media with power 80% with paired T-test 128 couples will be needed.
Randomization Couples will be enrolled in the study after fertilization check (day 1). A minimum of 6 zygotes is required for participation.
Stratified randomization of the zygotes by couple will be performed. For each couple the zygotes will be numbered.
These zygotes for each couple will then be block (by two) randomized to the two media types; A (Traditional culture media = Control) and B (Antioxidant media = intervention). In both groups traditional culture will be performed. Allocation will be performed in a 1:1 ratio according to a unique randomization list for each couple.
Blinding To minimize possible bias for the primary outcome (GQE D5) the embryologist performing the morphological evaluation on day 5/6 will not know which group the embryos belong to.
Both the physician and the couple will be blinded to which group they have been allocated.
IVF treatment procedure A traditional IVF treatment will be performed including ovarian stimulation and oocyte pick-up using the standard methods at the clinics.
Embryo assessment and timing of assessment according to Alpha/ESHRE consensus criteria.
Morphological scoring Blastocyst morphology will be scored according to Consensus Scoring system for blastocysts (Istanbul Consensus workshop on embryo assessment) and the morphology will be documented with individual photos of each blastocyst. Blastocyst scoring will be performed under an inverted microscope on day 5 and day 6. A good quality blastocyst is defined as at least Grade 2:2:2 according to Istanbul Consensus grading system. (Balaban et al., 2011).
DOCUMENTATION All patients participating in the study will be documented on a computerized CRF. This document will be related to patients' records with all relevant clinical and laboratory data from the specific IVF cycle. Through the journal system (WinIVF) used at Fertilitetscentrum, it will be possible to generate a complete list of all the variables included in the study.
Patients who have been asked to participate in the study but did not fulfill the criteria for randomization will also be registered.
STATISTICAL ANALYSIS Both an Intention-to-Treat (ITT) population and a Per Protocol (PP) population will be defined. Primary efficacy variable in this superiority study will be difference in %GQB between the two media types for each couple. Primary statistical analysis will be two-sided paired T-test regarding the mean of difference in %GQB between Standard culture media and Antioxidant media on the ITT population. A two sided 95% confidence interval for the mean difference in %GOB between the two media will be calculated. All significance tests will be two-sided and conducted at the 5% significance level.
- Conditions
- Culture Media, Blastocyst, Antioxidants, Embryo, Human
- Being tested
- Acetyl-L-carnitine (ALC), N-acetyl-L-cysteine (NAC) and α-lipoic acid (ALA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetyl-L-carnitine (ALC), N-acetyl-L-cysteine (NAC) and α-lipoic acid (ALA)Biological
Human embryos will be cultured in media that contains 3 antioxidants (Acetyl-L-carnitine (ALC), N-acetyl-L-cysteine (NAC) and α-lipoic acid (ALA)) that can be found in the in vivo Environment.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Culture media without addition of antioxidants |
| Treatment | Active comparator | Culture media with the addition of antioxidants Receives: Biological: Acetyl-L-carnitine (ALC), N-acetyl-L-cysteine (NAC) and α-lipoic acid (ALA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of good quality blastocysts (GQB) per randomized embryo
Measured: 7 months
Secondary outcomes (6)
Pregnancy rate
Measured: 10 months
Utilization rate
Measured: 7 months
Embryo development (Kinetics) day 3,5 & 6
Measured: 7 months
Implantation rate
Measured: 8 months
Embryo quality dag 3,5 and 6
Measured: 7 months
Total blastocyst rate
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Culture MediaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fertilitetscentrum AB
- Sponsor type
- University, hospital or other
- Collaborators
- Vitrolife
- Responsible party
- Principal investigator, Thorir Hardarson, Fertilitetscentrum AB
- Investigators
- Thorir Hardarson, PhD, Study chair, Fertilitetscentrum AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971878
- Sponsor's protocol ID
- GTL-X
- Status last verified
- Feb 2018
- First submitted
- 17 Nov 2016
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding Antioxidants Into Human Embryo Culture Media
- ClinicalTrials.gov ID
- NCT02971878
- Acronym / sponsor ID
- GTL-X
- Conditions
- Culture Media, Blastocyst, Antioxidants, Embryo, Human
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Fertilitetscentrum ABUniversity, hospital or other
- Collaborators
- Vitrolife
- Study start
- Nov 2016
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 23 Nov 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.
Aim: To investigate the impact of antioxidants (acetyl-L-carnitine, N-acetyl-L-cysteine and a-lipoic acid) on embryo development and subsequently the clinical outcome. Including clinics using low oxygen and ambient air during embryo culture. Analysed with time-lapse system.
Study media: G-TL with antioxidants. Control media: Same media without antioxidants. Type of study: Study comparing blastocyst development on the same cohort of oocytes using two different media, G-TL versus G-TL supplemented with antioxidants. Statistics based on an absolute increase in Good Quality Blastocysts on day 5 of 7%.
Design: Multicentre prospective randomized sibling trial. Single blastocyst transfer. Superiority study Primary Endpoint: Good Quality Blastocysts on day 5 per allocated normally fertilized oocyte.
Patients: Comparative embryo sibling study with 128 patients included.
Detailed description
Study objective: Study comparing blastocyst development on the same cohort of oocytes using two different media, G-TL versus G-TL supplemented with antioxidants.
Primary endpoint: Percentage of good quality blastocysts (GQB) per fertilized oocyte on day 5.
Secondary endpoints
- Embryo development day 3, 5 and 6
- Embryo quality day 3, 5 and 6
- Total blastocyst formation (day 5 and day 6)
- Utilization rate (embryos available for transfer and cryopreservation)
- Implantation rate
- Clinical pregnancy rate
Setup: Prospective embryo sibling, superiority study
MATERIALS AND METHODS Intervention New type of embryo culture media used for in vitro culture of human IVF embryos.
Power analysis The planning and the power analysis was made together with a statistician, Nils-Gunnar Pehrsson.
From retrospective data using simulation, the intra individual SD for the difference in % GQB between the two media strategies was estimated to 32%. In order to find a difference in 8% in GQB between the two media with power 80% with paired T-test 128 couples will be needed.
Randomization Couples will be enrolled in the study after fertilization check (day 1). A minimum of 6 zygotes is required for participation.
Stratified randomization of the zygotes by couple will be performed. For each couple the zygotes will be numbered.
These zygotes for each couple will then be block (by two) randomized to the two media types; A (Traditional culture media = Control) and B (Antioxidant media = intervention). In both groups traditional culture will be performed. Allocation will be performed in a 1:1 ratio according to a unique randomization list for each couple.
Blinding To minimize possible bias for the primary outcome (GQE D5) the embryologist performing the morphological evaluation on day 5/6 will not know which group the embryos belong to.
Both the physician and the couple will be blinded to which group they have been allocated.
IVF treatment procedure A traditional IVF treatment will be performed including ovarian stimulation and oocyte pick-up using the standard methods at the clinics.
Embryo assessment and timing of assessment according to Alpha/ESHRE consensus criteria.
Morphological scoring Blastocyst morphology will be scored according to Consensus Scoring system for blastocysts (Istanbul Consensus workshop on embryo assessment) and the morphology will be documented with individual photos of each blastocyst. Blastocyst scoring will be performed under an inverted microscope on day 5 and day 6. A good quality blastocyst is defined as at least Grade 2:2:2 according to Istanbul Consensus grading system. (Balaban et al., 2011).
DOCUMENTATION All patients participating in the study will be documented on a computerized CRF. This document will be related to patients' records with all relevant clinical and laboratory data from the specific IVF cycle. Through the journal system (WinIVF) used at Fertilitetscentrum, it will be possible to generate a complete list of all the variables included in the study.
Patients who have been asked to participate in the study but did not fulfill the criteria for randomization will also be registered.
STATISTICAL ANALYSIS Both an Intention-to-Treat (ITT) population and a Per Protocol (PP) population will be defined. Primary efficacy variable in this superiority study will be difference in %GQB between the two media types for each couple. Primary statistical analysis will be two-sided paired T-test regarding the mean of difference in %GQB between Standard culture media and Antioxidant media on the ITT population. A two sided 95% confidence interval for the mean difference in %GOB between the two media will be calculated. All significance tests will be two-sided and conducted at the 5% significance level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Culture media without addition of antioxidants |
| Treatment | Active comparator | Biological: Acetyl-L-carnitine (ALC), N-acetyl-L-cysteine (NAC) and α-lipoic acid (ALA)Culture media with the addition of antioxidants |
Who may qualify
- Ages
- 20 to 41 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Couples with female, male or unexplained infertility intending to undergo IVF
- The couple should have received verbal and written information/consent about the study.
- 6 or more fertilized oocytes on day 1
- Blastocyst culture and transfer on day 5
- Signed written consent
Key exclusion criteria (5 listed)
- Previous participation in the study.
- Testicular biopsy patients (TESA/TESE)
- Fewer than 6 fertilized oocytes.
- If split IVF is needed.
- Total freeze on day 3
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 |
|---|---|---|
| Acetyl-L-carnitine (ALC), N-acetyl-L-cysteine (NAC) and α-lipoic acid (ALA)Human embryos will be cultured in media that contains 3 antioxidants (Acetyl-L-carnitine (ALC), N-acetyl-L-cysteine (NAC) and α-lipoic acid (ALA)) that can be found in the in vivo Environment. | Biological | Treatment |
Primary outcome
Percentage of good quality blastocysts (GQB) per randomized embryo
Time frame: 7 months
6 secondary outcomes
Pregnancy rate
Time frame: 10 months
Utilization rate
Time frame: 7 months
Embryo development (Kinetics) day 3,5 & 6
Time frame: 7 months
Implantation rate
Time frame: 8 months
Embryo quality dag 3,5 and 6
Time frame: 7 months
Total blastocyst rate
Time frame: 7 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 22 Feb 2018.
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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.
Thorir Hardarson, PhD study chair
Fertilitetscentrum AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetyl-L-carnitine (ALC), N-acetyl-L-cysteine (NAC) and α-lipoic acid (ALA) in people with Culture Media and Blastocyst, run by Fertilitetscentrum AB at 1 site in Sweden.
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 5 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 22 Feb 2018. 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 Sweden. 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?
Percentage of good quality blastocysts (GQB) per randomized embryo (time frame: 7 months). 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 22 Feb 2018.