InfertilityNCT02516020
Effectiveness of Single Step Culture Media and Sequential Culture Media on Blastulation Rate
A study testing Global and Origio in people with Infertility, run by Vietnam National University at 1 site in Vietnam.
Trial summary
To compare the effectiveness of single step culture media and continuous uninterrupted culture media on blastulation rate Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Global and Origio
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteVietnam
- Study dates
- Aug 2015to Dec 2016
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Number of previous failure IVF cycles ≤2
- Using Gonadotropin-releasing hormone (GnRH) - Antagonist protocol for IVF
- Using GnRH for oocyte triggering.
- Read and sign consent form to participate in the study and have not been recruited for any other researches.
Who cannot join
- Oocyte donation cycles
- Abnormal uterine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Single Step Culture Media and Sequential Culture Media on Blastulation Rate: a Randomized Controlled Trial.
To compare the effectiveness of single step culture media and continuous uninterrupted culture media on blastulation rate
Read the detailed description
Sequential culture media are designed to mimic the changing environment in the ovary ducts and the uterus in vivo. However, there are some differences between in vivo and in vitro culture conditions. Hence, single step media are created which allow the embryo itself to choose the necessary nutrients while maintaining a more stable culture environment. Previous studies suggest higher blastulation rate in the single step media than the sequential media.
This is an Randomized controlled trial (RCT) study comparing the blastulation rate of single step culture media and sequential culture media. Stimulation protocol is antagonist. Patient will be consulted on the day of ultrasound if they meet the inclusion criteria and sign the consent form. Then, the nurse will open the letter containing the type of media for that case. The media is prepared inside the lab a day before oocyte pick-up.
After oocyte pick-up, the oocyte-cumulus complex (OCC) will be cultured for 2 hours at 37°C, 6% Carbon dioxide (CO2) and 5% oxygen (O2). Meanwhile, sperm preparation will be performed using gradient technique. After 2 hours, OCC will be denuded and will be cultured for 1 hour until Intracytoplasmic Sperm Injection (ICSI). Oocytes after ICSI will be cultured in groups of 3-4 oocytes in the same conditions of 37 ° C, 6% CO2 and 5% O2. Fertilization check procedure is at 16-18 hours after ICSI. On day 3, the embryos will be evaluated in 66-68 hours after ICSI, grade 1 embryos are identified with 7-9 blastomeres and fragmentation is from 0-10%. The patients will be informed about the embryo quality. If the embryos are not decided to have day 5 transferring, patient will be consulted to transfer on day 3. Blastulation rate will not be recorded.
For the sequential culture media group, embryos will be transferred to Sequential Blast medium. For the single step culture media group, embryos will be transferred to the new culture dish with the same medium. On day 5, embryo quality assessment will be at 116±1 hours after ICSI. Blastocyst grading is based on the expansion, inner cell mass quality, and trophectoderm quality. Two good blastocyst will be transferred. After 11 days, beta-human chorionic gonadotropin (hCG) test will be required. If the beta-hCG result is positive, examination will be needed after 3 weeks and the luteal support will be given until 7 weeks.
- Conditions
- Infertility
- Being tested
- Global, Origio
- Keywords
- IVF, ICSI, culture media, sequential
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlobalDrug
Also called Global medium (LifeGlobal)
Embryos are cultured in single step culture from day 1 to day 5
OrigioDrug
Also called Sequential Blast (Origio)
Embryos are cultured in sequential medium from Day1 to Day 3 and from Day 3 to Day 5 (Sequential Blast)
| Study group | Role | What they receive |
|---|---|---|
| Global | Active comparator | EmbryoSingle step culture medium Embryos are cultured in single step culture from day 1 to day 5 Other Name: Global medium (LifeGlobal) Receives: Drug: Global |
| Origio | Active comparator | Sequential media Embryos are cultured in sequential medium from Day1 to Day 3 and from Day 3 to Day 5 (Sequential Blast) Other Name: Sequential Blast (Origio) Receives: Drug: Origio |
What is being measured
The primary outcome is the main question the study is designed to answer.
The blastulation rate
The blastulation rate is defined as the number of blastocysts from 2 pronuclei (2PN) zygotes
Measured: 116 ±1 hours after ICSI
Secondary outcomes (2)
Implantation rate
Implantation rate is defined as the number of gestational sacs per number of embryos transferred.
Measured: 11 days after embryo transfer
Clinical pregnancy
Clinical pregnancy is defined by the image gestational sac under ultrasonography.
Measured: 7 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vietnam National University
- Sponsor type
- University, hospital or other
- Collaborators
- Mỹ Đức Hospital
- Responsible party
- Principal investigator, Manh Tuong Ho, Vietnam National University
- Investigators
- Tuong M Ho, MD, Principal investigator, Research Center for Genetics and Reproductive Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516020
- Sponsor's protocol ID
- NCKH/CGRH_ 05_2015
- Status last verified
- Apr 2017
- First submitted
- 3 Aug 2015
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Single Step Culture Media and Sequential Culture Media on Blastulation Rate: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02516020
- Acronym / sponsor ID
- NCKH/CGRH_ 05_2015
- Conditions
- Infertility
- Keywords
- IVF, ICSI, culture media, sequential
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vietnam National UniversityUniversity, hospital or other
- Collaborators
- Mỹ Đức Hospital
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 5 Aug 2015 (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.
To compare the effectiveness of single step culture media and continuous uninterrupted culture media on blastulation rate
Detailed description
Sequential culture media are designed to mimic the changing environment in the ovary ducts and the uterus in vivo. However, there are some differences between in vivo and in vitro culture conditions. Hence, single step media are created which allow the embryo itself to choose the necessary nutrients while maintaining a more stable culture environment. Previous studies suggest higher blastulation rate in the single step media than the sequential media.
This is an Randomized controlled trial (RCT) study comparing the blastulation rate of single step culture media and sequential culture media. Stimulation protocol is antagonist. Patient will be consulted on the day of ultrasound if they meet the inclusion criteria and sign the consent form. Then, the nurse will open the letter containing the type of media for that case. The media is prepared inside the lab a day before oocyte pick-up.
After oocyte pick-up, the oocyte-cumulus complex (OCC) will be cultured for 2 hours at 37°C, 6% Carbon dioxide (CO2) and 5% oxygen (O2). Meanwhile, sperm preparation will be performed using gradient technique. After 2 hours, OCC will be denuded and will be cultured for 1 hour until Intracytoplasmic Sperm Injection (ICSI). Oocytes after ICSI will be cultured in groups of 3-4 oocytes in the same conditions of 37 ° C, 6% CO2 and 5% O2. Fertilization check procedure is at 16-18 hours after ICSI. On day 3, the embryos will be evaluated in 66-68 hours after ICSI, grade 1 embryos are identified with 7-9 blastomeres and fragmentation is from 0-10%. The patients will be informed about the embryo quality. If the embryos are not decided to have day 5 transferring, patient will be consulted to transfer on day 3. Blastulation rate will not be recorded.
For the sequential culture media group, embryos will be transferred to Sequential Blast medium. For the single step culture media group, embryos will be transferred to the new culture dish with the same medium. On day 5, embryo quality assessment will be at 116±1 hours after ICSI. Blastocyst grading is based on the expansion, inner cell mass quality, and trophectoderm quality. Two good blastocyst will be transferred. After 11 days, beta-human chorionic gonadotropin (hCG) test will be required. If the beta-hCG result is positive, examination will be needed after 3 weeks and the luteal support will be given until 7 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Global | Active comparator | Drug: GlobalEmbryoSingle step culture medium Embryos are cultured in single step culture from day 1 to day 5 Other Name: Global medium (LifeGlobal) |
| Origio | Active comparator | Drug: OrigioSequential media Embryos are cultured in sequential medium from Day1 to Day 3 and from Day 3 to Day 5 (Sequential Blast) Other Name: Sequential Blast (Origio) |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Number of previous failure IVF cycles ≤2
- Using Gonadotropin-releasing hormone (GnRH) - Antagonist protocol for IVF
- Using GnRH for oocyte triggering.
- Read and sign consent form to participate in the study and have not been recruited for any other researches.
Key exclusion criteria (2 listed)
- Oocyte donation cycles
- Abnormal uterine.
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 |
|---|---|---|
| GlobalAlso: Global medium (LifeGlobal)Embryos are cultured in single step culture from day 1 to day 5 | Drug | Global |
| OrigioAlso: Sequential Blast (Origio)Embryos are cultured in sequential medium from Day1 to Day 3 and from Day 3 to Day 5 (Sequential Blast) | Drug | Origio |
Primary outcome
The blastulation rate
Time frame: 116 ±1 hours after ICSI
The blastulation rate is defined as the number of blastocysts from 2 pronuclei (2PN) zygotes
2 secondary outcomes
Implantation rate
Time frame: 11 days after embryo transfer
Clinical pregnancy
Time frame: 7 weeks after embryo transfer
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
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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.
Tuong M Ho, MD principal investigator
Research Center for Genetics and Reproductive Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Global and Origio in people with Infertility, run by Vietnam National University at 1 site in Vietnam.
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: withdrawn, as of the sponsor's last update on 18 Apr 2017. 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 Vietnam. 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 was withdrawn before enrolling participants, so there are no results.
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?
The blastulation rate (time frame: 116 ±1 hours after ICSI). 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 18 Apr 2017.