AI-Assisted Euploid Embryo Selection for Single-Blastocyst Transfer in Women of Advanced Maternal Age
Effects of Multimodal AI-Assisted Noninvasive Euploid Embryo Selection on Clinical Outcomes After Single-Blastocyst Transfer in Women of Advanced Maternal Age: A Prospective Randomized Controlled Trial
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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Shanshan Wang
- Número de telefone: +86-13814549922
- E-mail: wss_19860820@sina.com
Locais de estudo
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Jiangsu
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Nanjing, Jiangsu, China, 210028
- The Affliated Drum Tower Hospital of Nanjing University Medical School
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Contato:
- Shanshan Wang
- Número de telefone: +86-13814549922
- E-mail: wss_19860820@sina.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- (1) Infertile women aged ≥35 years. (2) Planned IVF or ICSI. (3) No more than two previous oocyte-retrieval cycles. (4) At least three usable day-3 embryos and eligibility for day-5 single-blastocyst transfer. (5) At least one day-5 blastocyst meeting transfer criteria, Gardner grade ≥3BB. (6) Voluntary written informed consent from both partners.
Exclusion Criteria:
- (1) PGT required because of chromosomal abnormalities. (2) Donor-oocyte, donor-sperm or thawed-oocyte cycles. (3) Severe uterine malformations, intrauterine adhesions, or infertility attributable solely to uterine factors. (4) Incomplete or unclear blastocyst images affecting AI assessment. (5) Other circumstances judged unsuitable by the investigator.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Falso: Control
EmbryoInsights™ for AI-assisted morphological assessment |
AI-assisted morphological assessment using EmbryoInsights™ |
|
Experimental: Experimental
EmbryoInsights™ Plus for morphological assessment combined with euploidy probability prediction |
AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ Plus |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Ongoing pregnancy rate
Prazo: From enrollment to 12 weeks of gestation ±7 days
|
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. |
From enrollment to 12 weeks of gestation ±7 days
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Clinical pregnancy rate
Prazo: From enrollment to 35 days after transfer.
|
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. |
From enrollment to 35 days after transfer.
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|
Early miscarriage rate
Prazo: From confirmation of clinical pregnancy to 12 weeks of gestation
|
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. |
From confirmation of clinical pregnancy to 12 weeks of gestation
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|
Live birth rate
Prazo: At delivery
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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. |
At delivery
|
Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NDTHNanjingUMS-820
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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