Ding Ling, Wang Nan, Jia Jialin, Long Chuan, Kuo Ying, Wang Xiaomeng, Xu Fanqing, Ren Yixin, Ma Mochen, Wang Zhongwei, Shi Xiaodan, Huang Jin, Zhu Xiaohui, Chen Lixue, Ji Yanbo, Liu Ping, Li Rong, Lian Ying, Qiao Jie, Yan Liying
State Key Laboratory of Female Fertility Promotion, Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China.
National Clinical Research Center for Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China.
Hum Reprod. 2025 Mar 1;40(3):434-441. doi: 10.1093/humrep/deaf001.
Does the number of biopsied trophectoderm cells sampled for preimplantation genetic testing for monogenic disease (PGT-M) affect subsequent clinical outcomes for those selected embryos?
The number of biopsied cells does not affect the pregnancy outcome of preimplantation genetically tested embryos.
The successful execution of PGT relies on the availability of a certain number of high-quality biopsied cells. Evidence in the literature has reported that blastocyst biopsies may have a negative impact on clinical outcomes.
STUDY DESIGN, SIZE, DURATION: A retrospective cohort study including 850 single-blastocyst transfer cycles from 605 couples between May 2014 and August 2024 was conducted at Peking University Third Hospital. The primary clinical outcome measure was the biochemical pregnancy rate, while other indicators such as the live birth rate, the clinical pregnancy rate, and the miscarriage rate were also recorded.
PARTICIPANTS/MATERIALS, SETTING, METHODS: This study included 850 blastocysts obtained from routine PGT-M cycles. Based on biopsied cell numbers, data were categorized into four groups: Group 1 (1-5 cells) (n = 234), Group 2 (6-10 cells) (n = 328), Group 3 (11-15 cells) (n = 192), and Group 4 (>15 cells) (n = 96).
The number of cells biopsied from the embryo did not significantly affect either the biochemical pregnancy rate or the live birth rate in the routine PGT process (P > 0.05). There were 129 of 234 embryos (55.1%) in the 1-5 biopsied cell group, 183 of the 328 embryos (55.8%) with 6-10 biopsied cells, 92 of 192 embryos (47.9%) with 11-15 biopsied cells, and 48 of 96 (50.0%) embryos with more than 15 biopsied cells which achieved successful pregnancies. The live birth rates were 42.7%, 49.7%, 43.2%, and 43.8% for each of the biopsy groups, respectively.
LIMITATIONS, REASONS FOR CAUTION: Data for this study were collected from one center only, therefore multicenter, large-scale cohort studies are essential to confirm the accuracy and the reliability of this study.
The number of biopsied cells in a blastocyst is associated with the embryo quality and hatching status. The conclusion of this study emphasizes that routine procedures during the biopsy process do not affect pregnancy outcomes. It is crucial to strike a balance between minimizing damage to the blastocyst's developmental potential and achieving the highest possible detection efficiency for PGT-M.
STUDY FUNDING/COMPETING INTEREST(S): This project is funded by the National Key Research and Development Program of China (2019YFA0801401, 2019YFA0110001) and the National Natural Science Foundation of China (82125013). The authors declare that they have no competing interests.
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用于单基因疾病植入前基因检测（PGT-M）的活检滋养外胚层细胞数量是否会影响那些被选中胚胎的后续临床结局？
活检细胞数量不影响经植入前基因检测胚胎的妊娠结局。
PGT的成功实施依赖于一定数量的高质量活检细胞。文献中的证据报告称囊胚活检可能对临床结局有负面影响。
研究设计、规模、持续时间：北京大学第三医院开展了一项回顾性队列研究，纳入了2014年5月至2024年8月期间605对夫妇的850个单囊胚移植周期。主要临床结局指标是生化妊娠率，同时还记录了其他指标，如活产率、临床妊娠率和流产率。
参与者/材料、设置、方法：本研究纳入了从常规PGT-M周期获得的850个囊胚。根据活检细胞数量，数据被分为四组：第1组（1 - 5个细胞）（n = 234），第2组（6 - 10个细胞）（n = 328），第3组（11 - 15个细胞）（n = 192），第4组（>15个细胞）（n = 96）。
在常规PGT过程中，从胚胎活检的细胞数量对生化妊娠率或活产率均无显著影响（P > 0.05）。活检细胞数为1 - 5个的234个胚胎中有129个（55.1%），活检细胞数为6 - 10个的328个胚胎中有183个（55.8%），活检细胞数为11 - 15个的192个胚胎中有92个（47.9%），活检细胞数超过15个的96个胚胎中有48个（50.0%）成功妊娠。各活检组的活产率分别为42.7%、49.7%、43.2%和43.8%。
局限性、谨慎原因：本研究数据仅从一个中心收集，因此多中心、大规模队列研究对于确认本研究的准确性和可靠性至关重要。
囊胚中活检细胞的数量与胚胎质量和孵化状态相关。本研究的结论强调活检过程中的常规操作不影响妊娠结局。在尽量减少对囊胚发育潜能的损害与实现PGT-M尽可能高的检测效率之间取得平衡至关重要。
研究资金/利益冲突：本项目由中国国家重点研发计划（2019YFA0801401，2019YFA0110001）和中国国家自然科学基金（82125013）资助。作者声明他们没有利益冲突。
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