An interventional study of AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ Plus and AI-assisted morphological assessment using EmbryoInsights™ in Female Infertility, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Not yet recruiting at 1 site in China. Open to female participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Not applicable, Interventional, and Other
This single-center prospective randomized controlled study will enroll 500 infertile women aged 35 years or older who meet the criteria for fresh day-5 single-blastocyst transfer. Participants will be allocated 1:1 to AI-assisted morphological assessment using EmbryoInsights™ or AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ Plus. The study evaluates whether adding euploidy prediction improves ongoing pregnancy after the first fresh transfer. Secondary outcomes are clinical pregnancy, early miscarriage and live birth. Maternal and infant safety will be monitored.
After routine ovarian stimulation, oocyte retrieval and IVF/ICSI, embryos will undergo closed time-lapse culture. Patients will be recruited and provide informed consent on day 3. Eligible patients will be randomized by the random envelope method in a 1:1 ratio on day 5. The control group uses EmbryoInsights™ for morphological assessment. The experimental group uses EmbryoInsights™ Plus to predict euploidy probability and rank morphologically transferable blastocysts, prioritizing those classified as predicted euploid and then using morphology. Senior embryology professionals and study clinicians make the final transfer decision. If AI results are unavailable or the system fails, routine manual assessment is used. An AI result alone does not automatically cancel transfer. The investigational euploidy-prediction model has already been developed. No additional embryo biopsy or biological sampling is required. Follow-up includes hCG at 14 days after transfer, ultrasound at 35 days, assessment at 12 gestational weeks (±7 days), fetal anatomy assessment at 20-24 weeks, delivery, and 42 days postpartum. The primary analysis of ongoing pregnancy will use the intention-to-treat (ITT) population, with all randomized participants analyzed in their originally assigned groups. A per-protocol (PP) analysis will also be performed.
552 studies on the registry are indexed under Infertility, Female; 137 are open to participants now.
This study's planned enrollment of 500 is above the median of 100 across 378 interventional studies indexed under Infertility, Female.
Browse Infertility, Female studies →The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 250 studies on the registry; 147 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
EmbryoInsights™ for AI-assisted morphological assessment
Other: AI-assisted morphological assessment using EmbryoInsights™
EmbryoInsights™ Plus for morphological assessment combined with euploidy probability prediction
Other: AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ Plus
AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ Plus
AI-assisted morphological assessment using EmbryoInsights™
Ongoing pregnancy rate
Ongoing pregnancy is defined as pregnancy reaching 12 weeks of gestation after transfer, with fetal cardiac activity confirmed by ultrasound. The ongoing pregnancy rate is the proportion of transfer cycles in the group that achieve ongoing pregnancy. This outcome is the sole basis for sample size estimation in this study. Assessment: ultrasound at 12 weeks of gestation ±7 days.
Time frame: From enrollment to 12 weeks of gestation ±7 days
Clinical pregnancy rate
Number of cycles with an intrauterine gestational sac detected by ultrasound at 6-8 weeks of gestation / total number of transfer cycles in the group ×100%. Assessment: ultrasound 35 days after transfer.
Time frame: From enrollment to 35 days after transfer.
Early miscarriage rate
Number of cycles with pregnancy loss after confirmation of clinical pregnancy and within 12 weeks of gestation / total number of clinical pregnancy cycles in the group ×100%. Assessment period: from confirmation of clinical pregnancy to 12 weeks of gestation.
Time frame: From confirmation of clinical pregnancy to 12 weeks of gestation
Live birth rate
Number of cycles resulting in delivery of a live infant at ≥24 weeks of gestation / total number of transfer cycles in the group ×100%. Assessment: at delivery.
Time frame: At delivery
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School →