The Focus is to Validate the Accuracy of a Non-invasive Artificial Intelligence Model for the Prediction of the Human Blastocyst PloidyNCT06762704
Evaluation of an Artificial Intelligence Model for the Prediction of Human Blastocyst Ploidy Without Invasive Procedures
An observational study of The Focus is to Validate the Accuracy of a Non-invasive Artificial Intelligence Model for the Prediction of the Human Blastocyst Ploidy and Preimplantation Genetic Testing (PGT), run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 5 sites in China.
Trial summary
The goal of this clinical trial is to evaluate an artificial intelligence model for the prediction of human blastocyst ploidy without invasive procedures in couples that receive preimplantation genetic testing. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- The Focus is to Validate the Accuracy of a Non-invasive Artificial Intelligence Model for the Prediction of the Human Blastocyst Ploidy, Preimplantation Genetic Testing (PGT)
- What is being tested?
- Video recording
- How many people
- 1,408 participants
- Where
- 5 sitesChina
- Study dates
- Feb 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: This study is a multi-center trial which will be conducted in five reproductive medicine centers in eight provinces (Jiangsu, Shanghai, Jiangxi, Shaanxi, and Anhui) across China. The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School will serve as the primary investigate center. Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Jiangxi Maternal and Child Health Hospital, Tangdu Hospital of Air Force Military Medical University, and The First Affiliated Hospital of USTC (Anhui Provincial Hospital) will serve as the participant investigate centers. Videos that include multi-view images of human blastocysts will be collected on Day 5/6 of culture. PGT-A results of these blastocysts will be collected 4-8 weeks after trophectoderm biopsy. The study is non-interventional, and results will not be used to make treatment decisions.
Who may be able to join
- Maternal age between 20 and 40; paternal age between 20 and 55.
- Preimplantation genetic testing (PGT) cycles, including PGT for aneuploidy, PGT for monogenic disorders (PGT-M) or PGT for structural chromosome defect (PGT-SR).
- Having at least one Day 5/6 blastocyst developed from two-pronuclear (2PN) embryo which is suitable for trophectoderm biopsy (i.e., degree of expansion: IV, and at least a grade better than C for trophectoderm and inner cell mass grading).
- Couples with written informed consent.
Who cannot join
- Couples with contraindications for IVF or PGT.
- Women with all oocytes frozen after retrieval.
- Couples who fail to follow the study protocol.
- Couples deemed ineligible for enrollment by the investigator in consideration of study protocol and treatment safety.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui, 230001
Limin Wu, 18963797080, wuliminmail@126.com
Limin Wu
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, 330046
Yan Zhao, 13807056599, zhaoyan1972009@163.com
Yan Zhao
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Shanshan Wang, 13814549922, wss_19860820@sina.com
Haixiang Sun
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Yun Sun, 13601634278, syun163@163.com
Yun Sun
Tangdu Hospital of Air Force Military Medical University
Xi'an, Shaanxi, 710024
Xiaohong Wang, 13991262559, wangxh919@fmmu.edu.cn
Xiaohong Wang
About this study
Official title: A Non-Invasive Artificial Intelligence Model for the Prediction of Human Blastocyst Ploidy: a Multi-Center, Prospective, Non-Randomized Validation Study
The goal of this clinical trial is to evaluate an artificial intelligence model for the prediction of human blastocyst ploidy without invasive procedures in couples that receive preimplantation genetic testing. The main questions it aims to answer are:
- Is an artificial intelligence model able to predict the ploidy status of a human blastocyst based on its 3D morphology?
- Do quantitative 3D morphological parameters of trophectoderm cells and inner cell mass have strong correlations with human blastocyst ploidy status?
Videos that include multi-view images of each blastocyst from participants will be collected on Day 5/6 of culture, and preimplantation genetic testing results of these blastocysts will be collected 4-8 weeks after trophectoderm biopsy.
Read the detailed description
Background:
A pilot study has been conducted at The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School from August 2023 to September 2024. Videos and preimplantation genetic testing (PGT) results from 144 blastocysts were retrospectively collected. The artificial intelligence (AI) model first reconstructed the 3D surface of the blastocysts from the videos, and then measured their 3D morphological parameters. Based on these parameters, the model predicted the ploidy status of the blastocysts, and the prediction outputs were compared with the PGT results. The prediction sensitivity, specificity, accuracy and AUC were 90.5%, 91.3%, 90.9% and 0.946, respectively.
Study design:
This is a multi-center, prospective, non-randomized, non-blinded, and single-group study. After being informed about the study and potential risks, all participants will write the informed consents. Videos and PGT results of Day 5/6 blastocysts from each participant will be collected. Blastocysts will be classified as euploid, mosaic, and aneuploid corresponding to <30%, 30-80%, and >80% aneuploidy, respectively. Embryo culture, biopsy, and transfer will follow the standard operating procedure (SOP) in the laboratory. The study is non-interventional, and results will not be used to make treatment decisions.
Sample size:
We plan to enroll ~1408 Day 5/6 blastocysts in this trial based on one-sample sensitivity and specificity analysis. Meta-analysis shows that the sensitivity and specificity of the existing AI models are 73.4% (3702/5047) and 69.6% (4892/7028), and those of the non-invasive chromosomal screening methods are 80.3% (678/844) and 73.3% (908/1238) for non-invasively predicting blastocyst ploidy status. This study is presumed to achieve a sensitivity of no less than 85% and a specificity of no less than 80% with a significance level of α = 0.05. A total of 1126 blastocysts are required to achieve a statistical power of 0.9. Assuming a ~20% dropout rate, a total of 1408 blastocysts are anticipated to be enrolled. This sample size calculation is based on the analysis of statistical power and will be regularly revisited/adjusted during the trial period to ensure a high statistical power is achieved.
Data management:
The electronic data capture (EDC) system will be used for data collection. A clinical research coordinator will be assigned at each hospital, and they are responsible for recording the videos and clinical data via the EDC system. A senior clinical research associate will inspect the data in the EDC system regularly among 5 hospitals. The Data Safety and Monitoring Committee (DSMC) is responsible for overseeing the entire research process and the EDC system. For incomplete or missing data in the EDC system, the DSMC will contact the investigators for clarification.
Statistical analysis:
Statistical analysis will be conducted using IBM SPSS Statistics 26. Categorical variables will be described by number and percentage, and numerical variables will be described by mean, standard deviation (SD) and range. The Chi-squared test will be performed to analyze trends in categorical variables, and the t-test will be performed to compare numerical variables among different groups. Pearson correlation will be used to analyze the linear relationship among numerical variables. All statistical tests are two-tailed. P-values of <0.05 will be considered statistically significant, and odd ratios (ORs) with 95% confidence interval (CI) will be calculated. Logistic regression will be used for multivariate analysis to calculate the adjusted odd ratios (aORs). The performance of the AI for blastocyst ploidy prediction will be evaluated by sensitivity, specificity, accuracy and AUC, with 95% confidence interval.
Missing data will be removed if the proportion of samples with missing values is very small relative to the total sample size. Otherwise, the average, maximum, minimum, medium, or regression model will be used to impute the missing values. Outliers will be treated as the missing data and addressed accordingly.
- Conditions
- The Focus is to Validate the Accuracy of a Non-invasive Artificial Intelligence Model for the Prediction of the Human Blastocyst Ploidy, Preimplantation Genetic Testing (PGT)
- Being tested
- Video recording
- Keywords
- Blastocyst Evaluation, Prediction of Human Blastocyst Ploidy, 3D Morphological Measurement of Human Blastocysts, Non-Invasive Evaluation of Human Blastocysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video recordingOther
Videos of rotating the blastocysts will be recorded during the preparation stage of trophectoderm (TE) biopsy. The focal plane starts from the middle plane of the blastocyst. and then moves downwards until individual TE cells and inner cell mass (ICM) are clearly visible. A biopsy micropipette is used to gently push the blastocyst and rotate the blastocyst each time by a small angle, for instance, smaller than 35° such that more than 10 images can be captured for the entire 360° rotation to achieve high-accuracy measurement. After the first 360° rotation, the second one will be conducted around the axis perpendicular to the previous axis to ensure the whole surface of the blastocyst is captured. The entire rotation process will be video recoded.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity = TP/(TP+FN). TP: number of outcomes where a euploid blastocyst is correctly predicted as euploidy. FN: number of outcomes where a euploid blastocyst is incorrectly predicted as aneuploidy. High sensitivity indicates strong ability for the prediction of euploid blastocysts.
Measured: Through study completion, an average of 1 year
Specificity
Specificity = TN/(TN+FP). TN: number of outcomes where an aneuploid blastocyst is correctly predicted as aneuploidy. FP: number of outcomes where an aneuploid blastocyst is incorrectly predicted as euploidy. High specificity indicates strong ability for the prediction of aneuploid blastocysts.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Accuracy
Accuracy evaluates the number of correct predictions of blastocyst ploidy over the total number of predictions
Measured: Through study completion, an average of 1 year
AUC
AUC is defined as the area under the receiver operating characteristic curve, which evaluates the overall model performance for predicting blastocyst ploidy regardless of classification threshold.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for The Focus is to Validate the Accuracy of a Non-invasive Artificial Intelligence Model for the Prediction of the Human Blastocyst PloidyStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,408 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, Jiangxi Maternal and Child Health Hospital, The Second Affiliated Hospital of Air Force Military Medical University, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
- Responsible party
- Principal investigator, Wang Shanshan, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Haixiang Sun, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762704
- Sponsor's protocol ID
- 2024-739-02
- Status last verified
- Jan 2025
- First submitted
- 31 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will be shared according to the data access criteria.
Publications
Scott RT Jr, Ferry K, Su J, Tao X, Scott K, Treff NR. Comprehensive chromosome screening is highly predictive of the reproductive potential of human embryos: a prospective, blinded, nonselection study. Fertil Steril. 2012 Apr;97(4):870-5. doi: 10.1016/j.fertnstert.2012.01.104. Epub 2012 Feb 2.
PubMed 22305103Wang L, Wang X, Liu Y, Ou X, Li M, Chen L, Shao X, Quan S, Duan J, He W, Shen H, Sun L, Yu Y, Cram DS, Leigh D, Yao Y. IVF embryo choices and pregnancy outcomes. Prenat Diagn. 2021 Dec;41(13):1709-1717. doi: 10.1002/pd.6042. Epub 2021 Oct 14.
PubMed 34480803Kushnir VA, Frattarelli JL. Aneuploidy in abortuses following IVF and ICSI. J Assist Reprod Genet. 2009 Mar;26(2-3):93-7. doi: 10.1007/s10815-009-9292-z. Epub 2009 Feb 18.
PubMed 19224361Kim JW, Lee WS, Yoon TK, Seok HH, Cho JH, Kim YS, Lyu SW, Shim SH. Chromosomal abnormalities in spontaneous abortion after assisted reproductive treatment. BMC Med Genet. 2010 Nov 3;11:153. doi: 10.1186/1471-2350-11-153.
PubMed 21044350Sciorio R, Dattilo M. PGT-A preimplantation genetic testing for aneuploidies and embryo selection in routine ART cycles: Time to step back? Clin Genet. 2020 Aug;98(2):107-115. doi: 10.1111/cge.13732. Epub 2020 Apr 6.
PubMed 32141057Munne S, Kaplan B, Frattarelli JL, Child T, Nakhuda G, Shamma FN, Silverberg K, Kalista T, Handyside AH, Katz-Jaffe M, Wells D, Gordon T, Stock-Myer S, Willman S; STAR Study Group. Preimplantation genetic testing for aneuploidy versus morphology as selection criteria for single frozen-thawed embryo transfer in good-prognosis patients: a multicenter randomized clinical trial. Fertil Steril. 2019 Dec;112(6):1071-1079.e7. doi: 10.1016/j.fertnstert.2019.07.1346. Epub 2019 Sep 21.
PubMed 31551155Rosenwaks Z, Handyside AH, Fiorentino F, Gleicher N, Paulson RJ, Schattman GL, Scott RT Jr, Summers MC, Treff NR, Xu K. The pros and cons of preimplantation genetic testing for aneuploidy: clinical and laboratory perspectives. Fertil Steril. 2018 Aug;110(3):353-361. doi: 10.1016/j.fertnstert.2018.06.002. No abstract available.
PubMed 30098682Belandres D, Shamonki M, Arrach N. Current status of spent embryo media research for preimplantation genetic testing. J Assist Reprod Genet. 2019 May;36(5):819-826. doi: 10.1007/s10815-019-01437-6. Epub 2019 Mar 21.
PubMed 30895497Cinnioglu C, Glessner H, Jordan A, Bunshaft S. A systematic review of noninvasive preimplantation genetic testing for aneuploidy. Fertil Steril. 2023 Aug;120(2):235-239. doi: 10.1016/j.fertnstert.2023.06.013. Epub 2023 Jun 24.
PubMed 37356468Alpha Scientists in Reproductive Medicine and ESHRE Special Interest Group of Embryology. The Istanbul consensus workshop on embryo assessment: proceedings of an expert meeting. Hum Reprod. 2011 Jun;26(6):1270-83. doi: 10.1093/humrep/der037. Epub 2011 Apr 18.
PubMed 21502182Ozgur K, Berkkanoglu M, Bulut H, Yoruk GDA, Candurmaz NN, Coetzee K. Single best euploid versus single best unknown-ploidy blastocyst frozen embryo transfers: a randomized controlled trial. J Assist Reprod Genet. 2019 Apr;36(4):629-636. doi: 10.1007/s10815-018-01399-1. Epub 2019 Jan 7.
PubMed 30617927Tiegs AW, Tao X, Zhan Y, Whitehead C, Kim J, Hanson B, Osman E, Kim TJ, Patounakis G, Gutmann J, Castelbaum A, Seli E, Jalas C, Scott RT Jr. A multicenter, prospective, blinded, nonselection study evaluating the predictive value of an aneuploid diagnosis using a targeted next-generation sequencing-based preimplantation genetic testing for aneuploidy assay and impact of biopsy. Fertil Steril. 2021 Mar;115(3):627-637. doi: 10.1016/j.fertnstert.2020.07.052. Epub 2020 Aug 28.
PubMed 32863013Chavez-Badiola A, Flores-Saiffe-Farias A, Mendizabal-Ruiz G, Drakeley AJ, Cohen J. Embryo Ranking Intelligent Classification Algorithm (ERICA): artificial intelligence clinical assistant predicting embryo ploidy and implantation. Reprod Biomed Online. 2020 Oct;41(4):585-593. doi: 10.1016/j.rbmo.2020.07.003. Epub 2020 Jul 5.
PubMed 32843306Diakiw SM, Hall JMM, VerMilyea MD, Amin J, Aizpurua J, Giardini L, Briones YG, Lim AYX, Dakka MA, Nguyen TV, Perugini D, Perugini M. Development of an artificial intelligence model for predicting the likelihood of human embryo euploidy based on blastocyst images from multiple imaging systems during IVF. Hum Reprod. 2022 Jul 30;37(8):1746-1759. doi: 10.1093/humrep/deac131.
PubMed 35674312Barnes J, Brendel M, Gao VR, Rajendran S, Kim J, Li Q, Malmsten JE, Sierra JT, Zisimopoulos P, Sigaras A, Khosravi P, Meseguer M, Zhan Q, Rosenwaks Z, Elemento O, Zaninovic N, Hajirasouliha I. A non-invasive artificial intelligence approach for the prediction of human blastocyst ploidy: a retrospective model development and validation study. Lancet Digit Health. 2023 Jan;5(1):e28-e40. doi: 10.1016/S2589-7500(22)00213-8.
PubMed 36543475
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Invasive Artificial Intelligence Model for the Prediction of Human Blastocyst Ploidy: a Multi-Center, Prospective, Non-Randomized Validation Study
- ClinicalTrials.gov ID
- NCT06762704
- Acronym / sponsor ID
- 2024-739-02
- Conditions
- The Focus is to Validate the Accuracy of a Non-invasive Artificial Intelligence Model for the Prediction of the Human Blastocyst Ploidy, Preimplantation Genetic Testing (PGT)
- Keywords
- Blastocyst Evaluation, Prediction of Human Blastocyst Ploidy, 3D Morphological Measurement of Human Blastocysts, Non-Invasive Evaluation of Human Blastocysts
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,408 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- RenJi Hospital, Jiangxi Maternal and Child Health Hospital, The Second Affiliated Hospital of Air Force Military Medical University, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
- Study start
- Feb 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Jan 2025 (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.
The goal of this clinical trial is to evaluate an artificial intelligence model for the prediction of human blastocyst ploidy without invasive procedures in couples that receive preimplantation genetic testing. The main questions it aims to answer are:
- Is an artificial intelligence model able to predict the ploidy status of a human blastocyst based on its 3D morphology?
- Do quantitative 3D morphological parameters of trophectoderm cells and inner cell mass have strong correlations with human blastocyst ploidy status?
Videos that include multi-view images of each blastocyst from participants will be collected on Day 5/6 of culture, and preimplantation genetic testing results of these blastocysts will be collected 4-8 weeks after trophectoderm biopsy.
Detailed description
Background:
A pilot study has been conducted at The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School from August 2023 to September 2024. Videos and preimplantation genetic testing (PGT) results from 144 blastocysts were retrospectively collected. The artificial intelligence (AI) model first reconstructed the 3D surface of the blastocysts from the videos, and then measured their 3D morphological parameters. Based on these parameters, the model predicted the ploidy status of the blastocysts, and the prediction outputs were compared with the PGT results. The prediction sensitivity, specificity, accuracy and AUC were 90.5%, 91.3%, 90.9% and 0.946, respectively.
Study design:
This is a multi-center, prospective, non-randomized, non-blinded, and single-group study. After being informed about the study and potential risks, all participants will write the informed consents. Videos and PGT results of Day 5/6 blastocysts from each participant will be collected. Blastocysts will be classified as euploid, mosaic, and aneuploid corresponding to <30%, 30-80%, and >80% aneuploidy, respectively. Embryo culture, biopsy, and transfer will follow the standard operating procedure (SOP) in the laboratory. The study is non-interventional, and results will not be used to make treatment decisions.
Sample size:
We plan to enroll ~1408 Day 5/6 blastocysts in this trial based on one-sample sensitivity and specificity analysis. Meta-analysis shows that the sensitivity and specificity of the existing AI models are 73.4% (3702/5047) and 69.6% (4892/7028), and those of the non-invasive chromosomal screening methods are 80.3% (678/844) and 73.3% (908/1238) for non-invasively predicting blastocyst ploidy status. This study is presumed to achieve a sensitivity of no less than 85% and a specificity of no less than 80% with a significance level of α = 0.05. A total of 1126 blastocysts are required to achieve a statistical power of 0.9. Assuming a ~20% dropout rate, a total of 1408 blastocysts are anticipated to be enrolled. This sample size calculation is based on the analysis of statistical power and will be regularly revisited/adjusted during the trial period to ensure a high statistical power is achieved.
Data management:
The electronic data capture (EDC) system will be used for data collection. A clinical research coordinator will be assigned at each hospital, and they are responsible for recording the videos and clinical data via the EDC system. A senior clinical research associate will inspect the data in the EDC system regularly among 5 hospitals. The Data Safety and Monitoring Committee (DSMC) is responsible for overseeing the entire research process and the EDC system. For incomplete or missing data in the EDC system, the DSMC will contact the investigators for clarification.
Statistical analysis:
Statistical analysis will be conducted using IBM SPSS Statistics 26. Categorical variables will be described by number and percentage, and numerical variables will be described by mean, standard deviation (SD) and range. The Chi-squared test will be performed to analyze trends in categorical variables, and the t-test will be performed to compare numerical variables among different groups. Pearson correlation will be used to analyze the linear relationship among numerical variables. All statistical tests are two-tailed. P-values of <0.05 will be considered statistically significant, and odd ratios (ORs) with 95% confidence interval (CI) will be calculated. Logistic regression will be used for multivariate analysis to calculate the adjusted odd ratios (aORs). The performance of the AI for blastocyst ploidy prediction will be evaluated by sensitivity, specificity, accuracy and AUC, with 95% confidence interval.
Missing data will be removed if the proportion of samples with missing values is very small relative to the total sample size. Otherwise, the average, maximum, minimum, medium, or regression model will be used to impute the missing values. Outliers will be treated as the missing data and addressed accordingly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study is a multi-center trial which will be conducted in five reproductive medicine centers in eight provinces (Jiangsu, Shanghai, Jiangxi, Shaanxi, and Anhui) across China. The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School will serve as the primary investigate center. Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Jiangxi Maternal and Child Health Hospital, Tangdu Hospital of Air Force Military Medical University, and The First Affiliated Hospital of USTC (Anhui Provincial Hospital) will serve as the participant investigate centers. Videos that include multi-view images of human blastocysts will be collected on Day 5/6 of culture. PGT-A results of these blastocysts will be collected 4-8 weeks after trophectoderm biopsy. The study is non-interventional, and results will not be used to make treatment decisions.
Key inclusion criteria (4 listed)
- Maternal age between 20 and 40; paternal age between 20 and 55.
- Preimplantation genetic testing (PGT) cycles, including PGT for aneuploidy, PGT for monogenic disorders (PGT-M) or PGT for structural chromosome defect (PGT-SR).
- Having at least one Day 5/6 blastocyst developed from two-pronuclear (2PN) embryo which is suitable for trophectoderm biopsy (i.e., degree of expansion: IV, and at least a grade better than C for trophectoderm and inner cell mass grading).
- Couples with written informed consent.
Key exclusion criteria (4 listed)
- Couples with contraindications for IVF or PGT.
- Women with all oocytes frozen after retrieval.
- Couples who fail to follow the study protocol.
- Couples deemed ineligible for enrollment by the investigator in consideration of study protocol and treatment safety.
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 |
|---|---|---|
| Video recordingVideos of rotating the blastocysts will be recorded during the preparation stage of trophectoderm (TE) biopsy. The focal plane starts from the middle plane of the blastocyst. and then moves downwards until individual TE cells and inner cell mass (ICM) are clearly visible. A biopsy micropipette is used to gently push the blastocyst and rotate the blastocyst each time by a small angle, for instance, smaller than 35° such that more than 10 images can be captured for the entire 360° rotation to achieve high-accuracy measurement. After the first 360° rotation, the second one will be conducted around the axis perpendicular to the previous axis to ensure the whole surface of the blastocyst is captured. The entire rotation process will be video recoded. | Other | – |
Primary outcome
Sensitivity
Time frame: Through study completion, an average of 1 year
Sensitivity = TP/(TP+FN). TP: number of outcomes where a euploid blastocyst is correctly predicted as euploidy. FN: number of outcomes where a euploid blastocyst is incorrectly predicted as aneuploidy. High sensitivity indicates strong ability for the prediction of euploid blastocysts.
Specificity
Time frame: Through study completion, an average of 1 year
Specificity = TN/(TN+FP). TN: number of outcomes where an aneuploid blastocyst is correctly predicted as aneuploidy. FP: number of outcomes where an aneuploid blastocyst is incorrectly predicted as euploidy. High specificity indicates strong ability for the prediction of aneuploid blastocysts.
2 secondary outcomes
Accuracy
Time frame: Through study completion, an average of 1 year
AUC
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Background: PubMed 22305103Scott RT Jr, Ferry K, Su J, Tao X, Scott K, Treff NR. Comprehensive chromosome screening is highly predictive of the reproductive potential of human embryos: a prospective, blinded, nonselection study. Fertil Steril. 2012 Apr;97(4):870-5. doi: 10.1016/j.fertnstert.2012.01.104. Epub 2012 Feb 2.
- Background: PubMed 34480803Wang L, Wang X, Liu Y, Ou X, Li M, Chen L, Shao X, Quan S, Duan J, He W, Shen H, Sun L, Yu Y, Cram DS, Leigh D, Yao Y. IVF embryo choices and pregnancy outcomes. Prenat Diagn. 2021 Dec;41(13):1709-1717. doi: 10.1002/pd.6042. Epub 2021 Oct 14.
- Background: PubMed 19224361Kushnir VA, Frattarelli JL. Aneuploidy in abortuses following IVF and ICSI. J Assist Reprod Genet. 2009 Mar;26(2-3):93-7. doi: 10.1007/s10815-009-9292-z. Epub 2009 Feb 18.
- Background: PubMed 21044350Kim JW, Lee WS, Yoon TK, Seok HH, Cho JH, Kim YS, Lyu SW, Shim SH. Chromosomal abnormalities in spontaneous abortion after assisted reproductive treatment. BMC Med Genet. 2010 Nov 3;11:153. doi: 10.1186/1471-2350-11-153.
- Background: PubMed 32141057Sciorio R, Dattilo M. PGT-A preimplantation genetic testing for aneuploidies and embryo selection in routine ART cycles: Time to step back? Clin Genet. 2020 Aug;98(2):107-115. doi: 10.1111/cge.13732. Epub 2020 Apr 6.
- Background: PubMed 31551155Munne S, Kaplan B, Frattarelli JL, Child T, Nakhuda G, Shamma FN, Silverberg K, Kalista T, Handyside AH, Katz-Jaffe M, Wells D, Gordon T, Stock-Myer S, Willman S; STAR Study Group. Preimplantation genetic testing for aneuploidy versus morphology as selection criteria for single frozen-thawed embryo transfer in good-prognosis patients: a multicenter randomized clinical trial. Fertil Steril. 2019 Dec;112(6):1071-1079.e7. doi: 10.1016/j.fertnstert.2019.07.1346. Epub 2019 Sep 21.
- Background: PubMed 30098682Rosenwaks Z, Handyside AH, Fiorentino F, Gleicher N, Paulson RJ, Schattman GL, Scott RT Jr, Summers MC, Treff NR, Xu K. The pros and cons of preimplantation genetic testing for aneuploidy: clinical and laboratory perspectives. Fertil Steril. 2018 Aug;110(3):353-361. doi: 10.1016/j.fertnstert.2018.06.002. No abstract available.
- Background: PubMed 30895497Belandres D, Shamonki M, Arrach N. Current status of spent embryo media research for preimplantation genetic testing. J Assist Reprod Genet. 2019 May;36(5):819-826. doi: 10.1007/s10815-019-01437-6. Epub 2019 Mar 21.
- Background: PubMed 37356468Cinnioglu C, Glessner H, Jordan A, Bunshaft S. A systematic review of noninvasive preimplantation genetic testing for aneuploidy. Fertil Steril. 2023 Aug;120(2):235-239. doi: 10.1016/j.fertnstert.2023.06.013. Epub 2023 Jun 24.
- Background: PubMed 21502182Alpha Scientists in Reproductive Medicine and ESHRE Special Interest Group of Embryology. The Istanbul consensus workshop on embryo assessment: proceedings of an expert meeting. Hum Reprod. 2011 Jun;26(6):1270-83. doi: 10.1093/humrep/der037. Epub 2011 Apr 18.
- Background: PubMed 30617927Ozgur K, Berkkanoglu M, Bulut H, Yoruk GDA, Candurmaz NN, Coetzee K. Single best euploid versus single best unknown-ploidy blastocyst frozen embryo transfers: a randomized controlled trial. J Assist Reprod Genet. 2019 Apr;36(4):629-636. doi: 10.1007/s10815-018-01399-1. Epub 2019 Jan 7.
- Background: PubMed 32863013Tiegs AW, Tao X, Zhan Y, Whitehead C, Kim J, Hanson B, Osman E, Kim TJ, Patounakis G, Gutmann J, Castelbaum A, Seli E, Jalas C, Scott RT Jr. A multicenter, prospective, blinded, nonselection study evaluating the predictive value of an aneuploid diagnosis using a targeted next-generation sequencing-based preimplantation genetic testing for aneuploidy assay and impact of biopsy. Fertil Steril. 2021 Mar;115(3):627-637. doi: 10.1016/j.fertnstert.2020.07.052. Epub 2020 Aug 28.
- Individual participant dataSharing planned: Yes. All collected IPD will be shared according to the data access criteria.
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.
Haixiang Sun principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Focus is to Validate the Accuracy of a Non-invasive Artificial Intelligence Model for the Prediction of the Human Blastocyst Ploidy and Preimplantation Genetic Testing (PGT), run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 5 sites 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shanshan Wang (13814549922, wss_19860820@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 NCT06762704, which also lists 23 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 8 Jan 2025.