Clinical Outcomes of Non-invasive Embryo Implantation Potential Assessment Versus Conventional Morphological Selection for Single Blastocyst Transfer Following Conventional IVF: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- Live birth rate of the first frozen embryo transfer
研究概览
简要总结
Background: Morphology-based embryo selection cannot detect aneuploidy, which is common in advanced maternal age and recurrent pregnancy loss. NICS-AI combines non-invasive chromosome screening (NICS) of cell-free DNA from spent blastocyst culture medium with AI integration of developmental day and morphology to improve embryo ranking.
Methods: This multicenter, single-blind, parallel randomized controlled trial will include 520 participants. Participants undergoing conventional IVF will be eligible if they meet either (i) female age 35-43 years or (ii) recurrent miscarriage (≥2 losses <28 gestational weeks, including biochemical pregnancy with serum hCG >25 IU/L). They must consent to blastocyst culture/vitrification and frozen-thawed single blastocyst transfer (SBT), and have ≥2 Day-5/Day-6, 2PN-derived blastocysts with morphology grade ≥4BC/4CB at randomization. Key exclusions include any ICSI-based fertilization or PGT-related procedures, known genetic disease meeting PGT indications, donor oocytes, untreated uterine anomalies/hydrosalpinx, or contraindications to pregnancy/ART.
Randomization/interventions: Participants will be randomized 1:1 to NICS-AI-guided selection or morphology-based selection. In the NICS-AI arm, culture-medium DNA is tested and an AI-derived composite implantation score ranks embryos; controls use morphology alone (tie-break by cryopreservation order).
Outcomes/analysis: The primary endpoint is live birth after the first SBT (delivery with ≥1 live-born infant per transfer cycle, per randomized participant). Secondary endpoints include first clinical pregnancy, early miscarriage (<12 weeks, excluding biochemical pregnancy), ongoing pregnancy to 12 weeks, and cumulative pregnancy/live birth outcomes within 1 year (≤3 SBTs from one retrieval). Safety includes fetal malformations and neonatal outcomes through 1 year postpartum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Conventional IVF insemination;
- •Meeting either of the following:
- •Advanced maternal age: female age 35-43 years;
- •Recurrent miscarriage: ≥2 spontaneous pregnancy losses (<28 gestational weeks), including biochemical pregnancy (hCG >25 IU/L) ;
- •Willingness to culture all Day 3 embryos to the blastocyst stage in the fresh cycle, or to culture ≥6 embryos (with at least one embryo ≥7 cells), and to cryopreserve all blastocysts as single-blastocyst vitrification;
- •Willingness to undergo frozen-thawed single-blastocyst transfer;
- •At least two blastocysts formed on Day 5/Day 6 from 2PN fertilization, with morphological grading ≥4BC/4CB;
- •Provision of written informed consent.
排除标准
- •Any use of intracytoplasmic sperm injection-based fertilization, including but not limited to ICSI, TESA, and PGT-related cycles;
- •Known monogenic disorders or chromosomal abnormalities at enrollment;
- •Patients who use donated eggs to achieve pregnancy;
- •Definite conditions affecting uterine cavity anatomy or endometrial receptivity, such as untreated uterine malformations (e.g., septate uterus, unicornuate uterus, didelphys uterus) or untreated hydrosalpinx;
- •Contraindications to pregnancy or to assisted reproductive technology;
- •Any other condition deemed by the investigators to make the participant unsuitable for this study.
研究组 & 干预措施
NICS-AI group
干预措施: NICS-AI (Other)
Morphology group
干预措施: Morphology group (Other)
结局指标
主要结局
Live birth rate of the first frozen embryo transfer
时间窗: At delivery (following the first frozen embryo transfer)
live birth: number of deliveries resulting in at least one live-born infant per embryo transfer cycle Live birth rate of the first frozen embryo transfer = (No. of deliveries with live-born infant(s) after the last embryo transfer / No. of randomized patients) × 100%
次要结局
- Clinical pregnancy rate of the first frozen embryo transfer(4 weeks after the first frozen embryo transfer)
- Early miscarriage rate of the first frozen embryo transfer(From clinical pregnancy confirmation to 12 gestational weeks (following the first frozen embryo transfer))
- Ongoing pregnancy rate of the first frozen embryo transfer(At 12 gestational weeks (following the first frozen embryo transfer))
- Cumulative clinical pregnancy rate(From the first single-blastocyst transfer; clinical pregnancy assessed at 4 weeks after each transfer; up to three transfers within 12 months after randomization.)
- Cumulative early miscarriage rate(From the first single-blastocyst transfer; follow-up through 12 gestational weeks for each pregnancy achieved (max 3 transfers within 12 months after randomization).)
- Cumulative ongoing pregnancy rate(From the first single-blastocyst transfer; follow-up through 12 gestational weeks for each pregnancy achieved (max 3 transfers within 12 months after randomization).)
- Cumulative live birth rate(From the first single-blastocyst transfer; assessed at delivery for pregnancies achieved within 12 months after randomization (max 3 transfers).)