Culture MediaAntioxidantsNCT02999958
Adding Antioxidants Into Human Sequential Culture Media System
A study testing Antioxidants in people with Culture Media and Blastocyst, run by Vitrolife at 2 sites in Japan.
Trial summary
Upon collection, human oocytes are fertilized and culture up to the blastocyst stage, followed by transfer and / or cryopreservation. Culture media systems have been developed that support each step of this process. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Culture Media, Blastocyst, Antioxidants
- What is being tested?
- Antioxidants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesJapan
- Study dates
- Dec 2016to May 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Minimum eight cumulus-oocyte-complexes.
- Couples with female, male or unexplained infertility intending to undergo IVF
- The couple should have received verbal and written information/consent about the study.
- Blastocyst culture and embryo transfer is decided.
- If the couple fulfills the criteria above their consent to participate must be given and documented in the couple's medical journal.
Who cannot join
- Previous participation in the study
- PGD/PGS
- Surgically retrieved sperm cells (TESA / TESE)
- If split IVF is needed
- Less than eight cumulus-oocyte-complexes
- More than thirty cumulus-oocyte-complexes
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Kuramoto Women´s Clinic
Fukuoka, 8120013
Kiba Park Clinic
Tokyo, 135-0042
About this study
Official title: Comparison of G-Series Media System With Antioxidants Versus Standard G-Series Media System
Upon collection, human oocytes are fertilized and culture up to the blastocyst stage, followed by transfer and / or cryopreservation. Culture media systems have been developed that support each step of this process. Although these culture media systems try to mimic the natural environment, several components of the in-vivo situation are not present in today´s media. One such component is anti-oxidants that may protect embryos against damage by reactive oxygen species.
This investigation aims to compare blastocyst development using 2 different types of culture media systems, one of which contains antioxidants. Patients having at least eight oocytes and meeting other inclusion criteria can be included in this investigation.
Read more
It is a prospective randomized multicenter study randomly dividing oocytes into two groups and assessing parameters of embryo development from fertilization up to blastocyst formation until day six. Embryos with acceptable developmental characteristics can be transferred into the uterus or cryopreserved for later use.
The investigation is designed as a superiority study comparing utilization rate of blastocysts per normally fertilized oocyte using both media systems. In patients receiving embryo transfer in the fresh treatment cycle, detection of clinical pregnancy by ultrasound after 12 weeks gestation is the final endpoint of the investigation.
Read the detailed description
Study objective:
Study comparing blastocyst development on the same cohort of oocytes using two different media systems, sequential G-Series media versus sequential G-Series media 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) Biochemical pregnancy rate Implantation rate Clinical pregnancy rate
Setup:
Prospective oocyte 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 at oocyte pick up (day 0). A minimum of 8 cumulus-oocyte-complexes is required for participation.
Stratified randomization of the oocytes by couple will be performed. For each couple the oocytes will be numbered.
These oocytes for each couple will then be block (by two) randomized to the two media types; A (Traditional G-Series media system = Control) and B (G-Series media system with antioxidant = 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 (GQB 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 in respect to from which group an embryo was selected for transfer.
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 on day 3 according to Alpha/ESHRE consensus criteria and on day 5 according to Gardner score.
Morphological scoring Embryo development and morphology on day 3 will be scored based on the Alpha/ESHRE Consensus criteria. Blastocyst development and morphology will be scored according to a published scoring system for blastocysts and will be documented with individual photos of each blastocyst. Embryo \& Blastocyst scoring will be performed under an inverted microscope on day 3 and days 5 \& 6, respectively. Blastocysts that have a score equal or higher than 3BB are considered as GQB.
DOCUMENTATION All patients participating in the study will be documented on a computerized CRF. This document will contain study-specific relevant clinical and laboratory data from the specific IVF cycle.
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 sequential 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, Oxygen
- Being tested
- Antioxidants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntioxidantsBiological
Also called Acetyl-L-carnitine (ALC), N-acetyl-L-cysteine (NAC), alpha-Lipoic acid (ALA)
In the Treatment Arm, the G-Series culture media system will be used with antioxidants
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Sequential culture media without addition of antioxidants |
| Treatment | Active comparator | Sequential culture media with the addition of antioxidants Receives: Biological: Antioxidants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of good quality blastocyst (GQB) per fertilized oocyte on day 5
Measured: 7 months
Secondary outcomes (7)
Embryo development on day 3, 5 & 6
Measured: 7 months
Embryo quality on day 3, 5 & 6
Measured: 7 months
Total blastocyst rate
Measured: 7 months
Blastocyst utilization rate per fertilized oocyte
Measured: 7 months
Biochemical pregnancy rate
Measured: 8 months
Clinical pregnancy rate
Measured: 9 months
Implantation rate
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMay 2018
- Study completionMay 2018
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 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitrolife
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- A Yoshida, MD, PhD, Principal investigator, Kiba Park Clinic, Tokyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999958
- Sponsor's protocol ID
- AOX-G_Series-2016
- Acronym
- Antioxidants
- Status last verified
- Nov 2018
- First submitted
- 16 Dec 2016
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Gardner DK, Lane M, Stevens J, Schlenker T, Schoolcraft WB. Blastocyst score affects implantation and pregnancy outcome: towards a single blastocyst transfer. Fertil Steril. 2000 Jun;73(6):1155-8. doi: 10.1016/s0015-0282(00)00518-5.
PubMed 10856474
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of G-Series Media System With Antioxidants Versus Standard G-Series Media System
- ClinicalTrials.gov ID
- NCT02999958
- Acronym / sponsor ID
- Antioxidants / AOX-G_Series-2016
- Conditions
- Culture Media, Blastocyst, Antioxidants, Embryo, Human, Oxygen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- VitrolifeIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 21 Dec 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.
Upon collection, human oocytes are fertilized and culture up to the blastocyst stage, followed by transfer and / or cryopreservation. Culture media systems have been developed that support each step of this process. Although these culture media systems try to mimic the natural environment, several components of the in-vivo situation are not present in today´s media. One such component is anti-oxidants that may protect embryos against damage by reactive oxygen species.
This investigation aims to compare blastocyst development using 2 different types of culture media systems, one of which contains antioxidants. Patients having at least eight oocytes and meeting other inclusion criteria can be included in this investigation.
It is a prospective randomized multicenter study randomly dividing oocytes into two groups and assessing parameters of embryo development from fertilization up to blastocyst formation until day six. Embryos with acceptable developmental characteristics can be transferred into the uterus or cryopreserved for later use.
The investigation is designed as a superiority study comparing utilization rate of blastocysts per normally fertilized oocyte using both media systems. In patients receiving embryo transfer in the fresh treatment cycle, detection of clinical pregnancy by ultrasound after 12 weeks gestation is the final endpoint of the investigation.
Detailed description
Study objective:
Study comparing blastocyst development on the same cohort of oocytes using two different media systems, sequential G-Series media versus sequential G-Series media 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) Biochemical pregnancy rate Implantation rate Clinical pregnancy rate
Setup:
Prospective oocyte 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 at oocyte pick up (day 0). A minimum of 8 cumulus-oocyte-complexes is required for participation.
Stratified randomization of the oocytes by couple will be performed. For each couple the oocytes will be numbered.
These oocytes for each couple will then be block (by two) randomized to the two media types; A (Traditional G-Series media system = Control) and B (G-Series media system with antioxidant = 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 (GQB 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 in respect to from which group an embryo was selected for transfer.
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 on day 3 according to Alpha/ESHRE consensus criteria and on day 5 according to Gardner score.
Morphological scoring Embryo development and morphology on day 3 will be scored based on the Alpha/ESHRE Consensus criteria. Blastocyst development and morphology will be scored according to a published scoring system for blastocysts and will be documented with individual photos of each blastocyst. Embryo \& Blastocyst scoring will be performed under an inverted microscope on day 3 and days 5 \& 6, respectively. Blastocysts that have a score equal or higher than 3BB are considered as GQB.
DOCUMENTATION All patients participating in the study will be documented on a computerized CRF. This document will contain study-specific relevant clinical and laboratory data from the specific IVF cycle.
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 sequential 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
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Sequential culture media without addition of antioxidants |
| Treatment | Active comparator | Biological: AntioxidantsSequential culture media with the addition of antioxidants |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Minimum eight cumulus-oocyte-complexes.
- Couples with female, male or unexplained infertility intending to undergo IVF
- The couple should have received verbal and written information/consent about the study.
- Blastocyst culture and embryo transfer is decided.
- If the couple fulfills the criteria above their consent to participate must be given and documented in the couple's medical journal.
Key exclusion criteria (6 listed)
- Previous participation in the study
- PGD/PGS
- Surgically retrieved sperm cells (TESA / TESE)
- If split IVF is needed
- Less than eight cumulus-oocyte-complexes
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 |
|---|---|---|
| AntioxidantsAlso: Acetyl-L-carnitine (ALC), N-acetyl-L-cysteine (NAC), alpha-Lipoic acid (ALA)In the Treatment Arm, the G-Series culture media system will be used with antioxidants | Biological | Treatment |
Primary outcome
Percentage of good quality blastocyst (GQB) per fertilized oocyte on day 5
Time frame: 7 months
7 secondary outcomes
Embryo development on day 3, 5 & 6
Time frame: 7 months
Embryo quality on day 3, 5 & 6
Time frame: 7 months
Total blastocyst rate
Time frame: 7 months
Blastocyst utilization rate per fertilized oocyte
Time frame: 7 months
Biochemical pregnancy rate
Time frame: 8 months
Clinical pregnancy rate
Time frame: 9 months
Implantation rate
Time frame: 8 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 3 Dec 2018.
- Results publication: PubMed 10856474Gardner DK, Lane M, Stevens J, Schlenker T, Schoolcraft WB. Blastocyst score affects implantation and pregnancy outcome: towards a single blastocyst transfer. Fertil Steril. 2000 Jun;73(6):1155-8. doi: 10.1016/s0015-0282(00)00518-5.
- Individual participant dataSharing planned: No
Related trials for Culture Media
Not yet recruiting
Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles
Embryo Culture, Embryo Culture Media
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.
A Yoshida, MD, PhD principal investigator
Kiba Park Clinic, Tokyo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antioxidants in people with Culture Media and Blastocyst, run by Vitrolife at 2 sites in Japan.
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 6 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 3 Dec 2018. 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 Japan. 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 blastocyst (GQB) per fertilized oocyte on day 5 (time frame: 7 months). 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 NCT02999958, 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 3 Dec 2018; AzTrials last refreshed its copy on 29 Oct 2026.