Top-grade EmbryoNCT02965222
A Study Select Top-grade Embryo by Time-lapse Imaging
A study testing the time-lapse videography in people with Top-grade Embryo, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
Trial summary
To establish embryo time-difference kinetics scoring model for embryo selection before embryo transfer. It is especially suitable for selective single embryo transfer, advanced infertile women, and patients with repeated transplant failure. Read more about this study
- Who is it for?
- Ages Up to 38 years, women only
- Conditions the study is for
- Top-grade Embryo
- What is being tested?
- the time-lapse videography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Dec 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 Up to 38 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- women under 38 years of age
- ≤2th cycle
- transplantation cycle
Who cannot join
- women with abnormal oocytes in the past(≥30%)
- women with other systemic diseases
- women with abnormal uterine cavity shown on hysterosalpingogram or saline infusion sonogram
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai first Maternity and Infant health hospital, Tong Ji University
Shanghai, Shanghai Municipality, 201204
About this study
To establish embryo time-difference kinetics scoring model for embryo selection before embryo transfer. It is especially suitable for selective single embryo transfer, advanced infertile women, and patients with repeated transplant failure. It can effectively improve clinical pregnancy rate, improve embryo implantation rate and Rate of return home. Reduce the risk of multiple pregnancies.
Read the detailed description
- BACKGROUND: At present, embryo selection in embryonic laboratories at various reproductive centers continues to follow conventional morphological assessments based on the time period provided by the 2016 Expert Consensus Guidelines for Laboratory Operations (revised from the Istanbul consensus) (discussion board), after insemination of the 1th-6th day (except the 4th day) to observe the specific time points of embryonic morphology, static observation, score, select the embryo. This method of observation of embryonic development is not comprehensive enough, and the lack of quantifiable recognized indicators . EmbryoScope Time-lapse culture system is the latest development of human assisted reproductive embryo from fertilization to blastocyst development. The time-lapse imaging system (TLI) is used to record the embryonic development process from fertilization to blastocyst formation. The timing of change plays a key role in the developmental potential of the embryo, such as the time of emergence and disappearance of pronucleus, the time of early cleavage, cleavage pattern and so on. At present, the latest 2016 Laboratory Operation Expert Consensus Guide (discussion board) provides a grading standard that does not objectively reflect specific information on morphological changes, such as cleavage patterns, the specific time of morphological changes, and so on for embryonic development and post- Determine the fate of embryos play a vital role. Due to the clinical diagnosis and treatment of the center of the standard, laboratory culture system, and the difference between the laboratory standard operation procedure,and embryonic development speed differences. Therefore, it is desirable to use the EmbryoScope Time-lapse culture system to find out the best timing of morphological changes of embryos in accordance with the laboratory culture system on the basis of the expert consensus time period. To establish an evaluation model of embryo morphology kinetics suitable for our laboratory. Embryology time-of-flight monitoring Morphological kinetics evaluation model is suitable for patients with in vitro fertilization/ intracytoplasmic sperm injection , especially for infertile women in assisted reproduction, women with repeated transplantation failure, women with fertility disorders requiring egg activation, Single embryo transfer of patients, effectively avoid multiple pregnancy, reduce the risk of multiple pregnancy. Selection of embryos with developmental potential for transplantation, improve embryo quality, improve the accuracy of embryo selection, contribute to successful pregnancy. But also can alleviate this part of the patient's mental stress, but also contribute to successful pregnancy. At the same time, for laboratory embryologists to provide more data reference, more human embryonic development information. At present, several large-scale centers are undergoing their own embryo laboratory kinetics of the scoring model. Shanshan Wang et al suggested that the cleavage pattern of embryos and time parameters combined to establish a new embryo screening model for single embryo transfer embryo, to obtain an ideal pregnancy outcome. EmbryoScope Time-lapse culture system and embryo selection, compared to the traditional culture system and the static morphology of the embryo selection, EmbryoScope Timelapse selection of transplanted embryos, the clinical pregnancy rate [3], EmbryoScope Time-lapse culture system, Significantly improved. The literature of N. Basile and P. Vime [4] suggests that blastocyst culture [10] plus the choice of embryo morphology kinetics may be the best treatment for improving clinical outcomes. Studies have been reported , time difference imaging system does not interfere with embryonic culture conditions in the case of interval 20 min, 5 min or 1 min to shoot images, and continued to the first 3 days or 5 days. In addition, the TLI image acquisition system can exclude some of the abnormal cleaved embryos that are considered to have "normal" developmental potential in static assessment. A number of studies have shown that the TLI culture system combined with the morphological scoring method to select the embryos obtained after transplantation compared with the purely morphological method of the choice of static embryos can be more satisfactory to patients with pregnancy outcomes . In this study, we compared the clinical outcomes of patients with two different culture routes, analyzed the advantages of TLI combined with morphological scoring methods, and established the model of embryonic time difference morphology kinetics in our laboratory. The aim of this study was to prospectively select embryos for selective single embryo transfer, advanced infertility women and patients with repeated graft failure to improve the clinical pregnancy rate and reduce the occurrence of multiple births.
- Trial design: Samples were selected according to the inclusion criteria, and groups A and B were grouped according to the random number table, with 40-50 patients in each group. The random number table is attached. In order to avoid the withdrawal of patients or other reasons not suitable for inclusion in the trial, the researchers increased the sample size, the random number table increased to 150. A group of patients with oocytes injecting human chorionic gonadotrophin (HCG) 38-40 hours intracytoplasmic sperm injection (ICSI), and then into the ordinary three-gas incubator, conventional fertilization 4hours ,the demolition of eggs into the ordinary three-chamber, after insemination .The embryos were evaluated and selected by the current morphological scoring method. The oocytes of Group B were taken ICSI after infecting HCG 38-40 hours . And then be placed in the Time-Lapse. The ovaries were placed in the Time-Lapse after 4Hhours fertilization, and the embryos were evaluated by time-lapse imaging (TLI). The cleavage pattern and time parameters for marker embryo development were recorded daily after insemination. (1) The rate of high-quality embryos (cleavage and blastocyst stage), clinical pregnancy rate and embryo implantation rate in group A and group B; (2) The cleavage pattern and time parameters of embryo in group B were analyzed retrospectively, And the quality of blastocysts were analyzed. Logistic regression analysis was used to establish the criteria of embryo selection. (Age> 38 years), patients with recurrent graft failure (number of cycles ≥ 3), the development of embryos in this part of the patients were observed by TLI.Results: (1) Embryonic development , Select high-quality embryos for transplantation, observation of pregnancy outcome.
- Statistical methods: The data were expressed as mean ± standard deviation (x ± s) or rate (%), and the data were analyzed by Statistical Package for the Social Sciences 23.0 software. The quartile method was used to classify the time parameters, and the advantage period of each parameter was calculated with the outcome of pregnancy and high quality blastocyst formation. Logistic regression analysis of clinical variables (cleavage patterns and time parameters) and the relationship between high-quality blastocysts, the rate of each group were compared using χ 2 test, P <0.05 for the difference was statistically significant.
- Quality control and quality assurance Patients will managed by the listed investigators who have adequate experience in managing assisted reproduction treatments.A Trial steering committee will be formed which will oversee the conduct of the trial.
- Data Handing and record keeping All data will be stored for three years. A desighnted research nurse will be responsible for data management including data coding,monitoring and verification.
- Conditions
- Top-grade Embryo
- Being tested
- the time-lapse videography
- Keywords
- blastocyst, pregnancy rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the time-lapse videographyDevice
The all oocytes will be placed in the Time-Lapes .The third day the top-grade embryo will be selected by time-lapse imaging (TLI) .
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | After injecting HCG 38- 40 hours , the patient's oocytes will be taken with ICSI , then placed in the Time-Lapse. The oocytes will be IVF after 4 hours and will be stripped surrounding cumulus cell ,then will be placed in the Time-Lapse.The third day the top-grade embryo will be selected by time-lapse imaging (TLI) . The cleavage pattern and time parameters for marker embryo development were recorded daily after insemination. Receives: Device: the time-lapse videography |
| Control arm | Experimental | The development of the embryos at time-lapse was recorded directly and was not disturbed by temperature changes. Receives: Device: the time-lapse videography |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate
numer of live birth per transfer cycle
Measured: 1 year
Secondary outcomes (2)
clinical pregnancy rate
Measured: 1year
implantation rate
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
Dec 2016Dec 2018
- First posted16 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Top-grade EmbryoStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965222
- Sponsor's protocol ID
- WY710628
- Status last verified
- Nov 2016
- First submitted
- 9 Nov 2016
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Basile N, Vime P, Florensa M, Aparicio Ruiz B, Garcia Velasco JA, Remohi J, Meseguer M. The use of morphokinetics as a predictor of implantation: a multicentric study to define and validate an algorithm for embryo selection. Hum Reprod. 2015 Feb;30(2):276-83. doi: 10.1093/humrep/deu331. Epub 2014 Dec 19.
PubMed 25527613Rubio I, Galan A, Larreategui Z, Ayerdi F, Bellver J, Herrero J, Meseguer M. Clinical validation of embryo culture and selection by morphokinetic analysis: a randomized, controlled trial of the EmbryoScope. Fertil Steril. 2014 Nov;102(5):1287-1294.e5. doi: 10.1016/j.fertnstert.2014.07.738. Epub 2014 Sep 11.
PubMed 25217875Payne D, Flaherty SP, Barry MF, Matthews CD. Preliminary observations on polar body extrusion and pronuclear formation in human oocytes using time-lapse video cinematography. Hum Reprod. 1997 Mar;12(3):532-41. doi: 10.1093/humrep/12.3.532.
PubMed 9130755
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Select Top-grade Embryo by Time-lapse Imaging
- ClinicalTrials.gov ID
- NCT02965222
- Acronym / sponsor ID
- WY710628
- Conditions
- Top-grade Embryo
- Keywords
- blastocyst, pregnancy rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 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.
To establish embryo time-difference kinetics scoring model for embryo selection before embryo transfer. It is especially suitable for selective single embryo transfer, advanced infertile women, and patients with repeated transplant failure. It can effectively improve clinical pregnancy rate, improve embryo implantation rate and Rate of return home. Reduce the risk of multiple pregnancies.
Detailed description
- BACKGROUND: At present, embryo selection in embryonic laboratories at various reproductive centers continues to follow conventional morphological assessments based on the time period provided by the 2016 Expert Consensus Guidelines for Laboratory Operations (revised from the Istanbul consensus) (discussion board), after insemination of the 1th-6th day (except the 4th day) to observe the specific time points of embryonic morphology, static observation, score, select the embryo. This method of observation of embryonic development is not comprehensive enough, and the lack of quantifiable recognized indicators . EmbryoScope Time-lapse culture system is the latest development of human assisted reproductive embryo from fertilization to blastocyst development. The time-lapse imaging system (TLI) is used to record the embryonic development process from fertilization to blastocyst formation. The timing of change plays a key role in the developmental potential of the embryo, such as the time of emergence and disappearance of pronucleus, the time of early cleavage, cleavage pattern and so on. At present, the latest 2016 Laboratory Operation Expert Consensus Guide (discussion board) provides a grading standard that does not objectively reflect specific information on morphological changes, such as cleavage patterns, the specific time of morphological changes, and so on for embryonic development and post- Determine the fate of embryos play a vital role. Due to the clinical diagnosis and treatment of the center of the standard, laboratory culture system, and the difference between the laboratory standard operation procedure,and embryonic development speed differences. Therefore, it is desirable to use the EmbryoScope Time-lapse culture system to find out the best timing of morphological changes of embryos in accordance with the laboratory culture system on the basis of the expert consensus time period. To establish an evaluation model of embryo morphology kinetics suitable for our laboratory. Embryology time-of-flight monitoring Morphological kinetics evaluation model is suitable for patients with in vitro fertilization/ intracytoplasmic sperm injection , especially for infertile women in assisted reproduction, women with repeated transplantation failure, women with fertility disorders requiring egg activation, Single embryo transfer of patients, effectively avoid multiple pregnancy, reduce the risk of multiple pregnancy. Selection of embryos with developmental potential for transplantation, improve embryo quality, improve the accuracy of embryo selection, contribute to successful pregnancy. But also can alleviate this part of the patient's mental stress, but also contribute to successful pregnancy. At the same time, for laboratory embryologists to provide more data reference, more human embryonic development information. At present, several large-scale centers are undergoing their own embryo laboratory kinetics of the scoring model. Shanshan Wang et al suggested that the cleavage pattern of embryos and time parameters combined to establish a new embryo screening model for single embryo transfer embryo, to obtain an ideal pregnancy outcome. EmbryoScope Time-lapse culture system and embryo selection, compared to the traditional culture system and the static morphology of the embryo selection, EmbryoScope Timelapse selection of transplanted embryos, the clinical pregnancy rate [3], EmbryoScope Time-lapse culture system, Significantly improved. The literature of N. Basile and P. Vime [4] suggests that blastocyst culture [10] plus the choice of embryo morphology kinetics may be the best treatment for improving clinical outcomes. Studies have been reported , time difference imaging system does not interfere with embryonic culture conditions in the case of interval 20 min, 5 min or 1 min to shoot images, and continued to the first 3 days or 5 days. In addition, the TLI image acquisition system can exclude some of the abnormal cleaved embryos that are considered to have "normal" developmental potential in static assessment. A number of studies have shown that the TLI culture system combined with the morphological scoring method to select the embryos obtained after transplantation compared with the purely morphological method of the choice of static embryos can be more satisfactory to patients with pregnancy outcomes . In this study, we compared the clinical outcomes of patients with two different culture routes, analyzed the advantages of TLI combined with morphological scoring methods, and established the model of embryonic time difference morphology kinetics in our laboratory. The aim of this study was to prospectively select embryos for selective single embryo transfer, advanced infertility women and patients with repeated graft failure to improve the clinical pregnancy rate and reduce the occurrence of multiple births.
- Trial design: Samples were selected according to the inclusion criteria, and groups A and B were grouped according to the random number table, with 40-50 patients in each group. The random number table is attached. In order to avoid the withdrawal of patients or other reasons not suitable for inclusion in the trial, the researchers increased the sample size, the random number table increased to 150. A group of patients with oocytes injecting human chorionic gonadotrophin (HCG) 38-40 hours intracytoplasmic sperm injection (ICSI), and then into the ordinary three-gas incubator, conventional fertilization 4hours ,the demolition of eggs into the ordinary three-chamber, after insemination .The embryos were evaluated and selected by the current morphological scoring method. The oocytes of Group B were taken ICSI after infecting HCG 38-40 hours . And then be placed in the Time-Lapse. The ovaries were placed in the Time-Lapse after 4Hhours fertilization, and the embryos were evaluated by time-lapse imaging (TLI). The cleavage pattern and time parameters for marker embryo development were recorded daily after insemination. (1) The rate of high-quality embryos (cleavage and blastocyst stage), clinical pregnancy rate and embryo implantation rate in group A and group B; (2) The cleavage pattern and time parameters of embryo in group B were analyzed retrospectively, And the quality of blastocysts were analyzed. Logistic regression analysis was used to establish the criteria of embryo selection. (Age> 38 years), patients with recurrent graft failure (number of cycles ≥ 3), the development of embryos in this part of the patients were observed by TLI.Results: (1) Embryonic development , Select high-quality embryos for transplantation, observation of pregnancy outcome.
- Statistical methods: The data were expressed as mean ± standard deviation (x ± s) or rate (%), and the data were analyzed by Statistical Package for the Social Sciences 23.0 software. The quartile method was used to classify the time parameters, and the advantage period of each parameter was calculated with the outcome of pregnancy and high quality blastocyst formation. Logistic regression analysis of clinical variables (cleavage patterns and time parameters) and the relationship between high-quality blastocysts, the rate of each group were compared using χ 2 test, P <0.05 for the difference was statistically significant.
- Quality control and quality assurance Patients will managed by the listed investigators who have adequate experience in managing assisted reproduction treatments.A Trial steering committee will be formed which will oversee the conduct of the trial.
- Data Handing and record keeping All data will be stored for three years. A desighnted research nurse will be responsible for data management including data coding,monitoring and verification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: the time-lapse videographyAfter injecting HCG 38- 40 hours , the patient's oocytes will be taken with ICSI , then placed in the Time-Lapse. The oocytes will be IVF after 4 hours and will be stripped surrounding cumulus cell ,then will be placed in the Time-Lapse.The third day the top-grade embryo will be selected by time-lapse imaging (TLI) . The cleavage pattern and time parameters for marker embryo development were recorded daily after insemination. |
| Control arm | Experimental | Device: the time-lapse videographyThe development of the embryos at time-lapse was recorded directly and was not disturbed by temperature changes. |
Who may qualify
- Ages
- Up to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- women under 38 years of age
- ≤2th cycle
- transplantation cycle
Key exclusion criteria (3 listed)
- women with abnormal oocytes in the past(≥30%)
- women with other systemic diseases
- women with abnormal uterine cavity shown on hysterosalpingogram or saline infusion sonogram
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 |
|---|---|---|
| the time-lapse videographyThe all oocytes will be placed in the Time-Lapes .The third day the top-grade embryo will be selected by time-lapse imaging (TLI) . | Device | Control arm, Intervention arm |
Primary outcome
live birth rate
Time frame: 1 year
numer of live birth per transfer cycle
2 secondary outcomes
clinical pregnancy rate
Time frame: 1year
implantation rate
Time frame: 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
- Background: PubMed 25527613Basile N, Vime P, Florensa M, Aparicio Ruiz B, Garcia Velasco JA, Remohi J, Meseguer M. The use of morphokinetics as a predictor of implantation: a multicentric study to define and validate an algorithm for embryo selection. Hum Reprod. 2015 Feb;30(2):276-83. doi: 10.1093/humrep/deu331. Epub 2014 Dec 19.
- Background: PubMed 25217875Rubio I, Galan A, Larreategui Z, Ayerdi F, Bellver J, Herrero J, Meseguer M. Clinical validation of embryo culture and selection by morphokinetic analysis: a randomized, controlled trial of the EmbryoScope. Fertil Steril. 2014 Nov;102(5):1287-1294.e5. doi: 10.1016/j.fertnstert.2014.07.738. Epub 2014 Sep 11.
- Background: PubMed 9130755Payne D, Flaherty SP, Barry MF, Matthews CD. Preliminary observations on polar body extrusion and pronuclear formation in human oocytes using time-lapse video cinematography. Hum Reprod. 1997 Mar;12(3):532-41. doi: 10.1093/humrep/12.3.532.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the time-lapse videography in people with Top-grade Embryo, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Nov 2016. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Wang, Master (86-20261423 ext. 2014, wangyutea7121@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth rate (time frame: 1 year). 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 NCT02965222, which also lists 3 linked publications.
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 16 Nov 2016.