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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Shanshan Wang
- 전화번호: +86-13814549922
- 이메일: wss_19860820@sina.com
연구 장소
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Jiangsu
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Nanjing, Jiangsu, 중국, 210028
- The Affliated Drum Tower Hospital of Nanjing University Medical School
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연락하다:
- Shanshan Wang
- 전화번호: +86-13814549922
- 이메일: wss_19860820@sina.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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가짜 비교기: Control
EmbryoInsights™ for AI-assisted morphological assessment |
AI-assisted morphological assessment using EmbryoInsights™ |
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실험적: Experimental
EmbryoInsights™ Plus for morphological assessment combined with euploidy probability prediction |
AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ Plus |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Ongoing pregnancy rate
기간: From enrollment to 12 weeks of gestation ±7 days
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Clinical pregnancy rate
기간: From enrollment to 35 days after transfer.
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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
기간: From confirmation of clinical pregnancy to 12 weeks of gestation
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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
기간: 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
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NDTHNanjingUMS-820
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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