Embryo selection through non-invasive preimplantation genetic testing with cell-free DNA in spent culture media: a protocol for a multicentre, double-blind, randomised controlled trial
Introduction Morphological evaluation is used to select embryos for in vitro fertilisation. However, it does not fully reflect the implantation potential. Preimplantation genetic testing for aneuploidies (PGT-A) can detect embryonic aneuploidy, but biopsy procedure is invasive. Currently, a non-inva...
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BMJ Publishing Group
2022-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/7/e057254.full |
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| author | Jie Qiao Yan Wang Rong Li Ping Liu Liang Hu Lin Zeng Guimin Hao Jin Huang Bing Yao Junzhao Zhao Juanzi Shi Liyi Cai Xiu-Xia Wang Yanwen Xu Yuanqing Yao Yichun Guan Weiping Qian Sijia Lu |
| author_facet | Jie Qiao Yan Wang Rong Li Ping Liu Liang Hu Lin Zeng Guimin Hao Jin Huang Bing Yao Junzhao Zhao Juanzi Shi Liyi Cai Xiu-Xia Wang Yanwen Xu Yuanqing Yao Yichun Guan Weiping Qian Sijia Lu |
| author_sort | Jie Qiao |
| collection | DOAJ |
| description | Introduction Morphological evaluation is used to select embryos for in vitro fertilisation. However, it does not fully reflect the implantation potential. Preimplantation genetic testing for aneuploidies (PGT-A) can detect embryonic aneuploidy, but biopsy procedure is invasive. Currently, a non-invasive PGT (ni-PGT) approach using spent medium is being evaluated. However, the clinical benefit of ni-PGT has not been clearly demonstrated. A multicentre randomised trial is needed to verify whether ni-PGT can be an new effective tool for evaluating embryos.Methods and analysis Overall, 1148 couples aged 35~42 (women) receiving in vitro fertilization–intracytoplasmic sperm injection are planned to be enrolled. Couples will be digitally randomised to (1) ni-PGT and (2) conventional morphology groups at a 1:1 treatment ratio. The primary outcome will be the ongoing pregnancy rate related to the first transfer cycle within 6 months after oocyte retrieval.Ethics and dissemination The study protocol is approved by the Ethics Committee of Peking University Third Hospital and the participating hospitals. The results will be disseminated through international conferences and scientific journals.Trial registration number NCT04339166. |
| format | Article |
| id | doaj-art-d578486a4c424a41a3da5238f7c2843d |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-d578486a4c424a41a3da5238f7c2843d2025-01-31T13:50:10ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2021-057254Embryo selection through non-invasive preimplantation genetic testing with cell-free DNA in spent culture media: a protocol for a multicentre, double-blind, randomised controlled trialJie Qiao0Yan Wang1Rong Li2Ping Liu3Liang Hu4Lin Zeng5Guimin Hao6Jin Huang7Bing Yao8Junzhao Zhao9Juanzi Shi10Liyi Cai11Xiu-Xia Wang12Yanwen Xu13Yuanqing Yao14Yichun Guan15Weiping Qian16Sijia Lu17National Clinical Research Centre for Obstetrical and Gynaecological Diseases, State Key Laboratory of Female Fertility Promotion, Ministry of Education Key Laboratory of Assisted Reproduction, Centre for Reproductive Medicine, National Centre for Healthcare Quality Management in Obstetrics, Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing, ChinaDepartment of Obstetrics and Gynecology, Sichuan University West China Second University Hospital, Chengdu, Sichuan, ChinaBeijing Key Laboratory of Reproductive Endocrinology and Assisted Reproductive Technology, Beijing, ChinaBeijing Key Laboratory of Reproductive Endocrinology and Assisted Reproductive Technology, Beijing, ChinaNational Clinical Research Center for Ocular Diseases, Eye Hospital, Wenzhou Medical University, Wenzhou, Zhejiang, ChinaResearch Centre of Clinical Epidemiology, Peking University Third Hospital, Beijing, ChinaSecond Hospital of Hebei Medical University, Shijiazhuang, Hebei, ChinaDepartment of Pathology, Shanghai Jiao Tong University Affiliated Sixth People`s Hospital, Shanghai, ChinaAffiliated Jinling Hospital, Nanjing, ChinaDepartment of Obstetrics and Gynecology, Wenzhou Medical College Second Affiliated Hospital, Wenzhou, ChinaTranslational Medicine Center, Northwest Women’s and Children’s Hospital, Xi`an, ChinaReproductive Medical Center of Hebei Maternity Hospital, Shijiazhuang, ChinaShengjing Hospital of China Medical University, Shenyang, ChinaCentre for Reproductive Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, ChinaDepartment of Obstetrics and Gynecology, Chinese People’s Liberation Army General Hospital, Beijing, ChinaReproductive Medicine Center, The Third Affiliated Hospital of Zhengzhou University, Zhengzhou, ChinaThe Center of Reproductive Medicine, Peking University Shenzhen Hospital, Shenzhen, Guangdong, ChinaXukang Medical Technology (Suzhou) Co., Ltd, Suzhou, ChinaIntroduction Morphological evaluation is used to select embryos for in vitro fertilisation. However, it does not fully reflect the implantation potential. Preimplantation genetic testing for aneuploidies (PGT-A) can detect embryonic aneuploidy, but biopsy procedure is invasive. Currently, a non-invasive PGT (ni-PGT) approach using spent medium is being evaluated. However, the clinical benefit of ni-PGT has not been clearly demonstrated. A multicentre randomised trial is needed to verify whether ni-PGT can be an new effective tool for evaluating embryos.Methods and analysis Overall, 1148 couples aged 35~42 (women) receiving in vitro fertilization–intracytoplasmic sperm injection are planned to be enrolled. Couples will be digitally randomised to (1) ni-PGT and (2) conventional morphology groups at a 1:1 treatment ratio. The primary outcome will be the ongoing pregnancy rate related to the first transfer cycle within 6 months after oocyte retrieval.Ethics and dissemination The study protocol is approved by the Ethics Committee of Peking University Third Hospital and the participating hospitals. The results will be disseminated through international conferences and scientific journals.Trial registration number NCT04339166.https://bmjopen.bmj.com/content/12/7/e057254.full |
| spellingShingle | Jie Qiao Yan Wang Rong Li Ping Liu Liang Hu Lin Zeng Guimin Hao Jin Huang Bing Yao Junzhao Zhao Juanzi Shi Liyi Cai Xiu-Xia Wang Yanwen Xu Yuanqing Yao Yichun Guan Weiping Qian Sijia Lu Embryo selection through non-invasive preimplantation genetic testing with cell-free DNA in spent culture media: a protocol for a multicentre, double-blind, randomised controlled trial BMJ Open |
| title | Embryo selection through non-invasive preimplantation genetic testing with cell-free DNA in spent culture media: a protocol for a multicentre, double-blind, randomised controlled trial |
| title_full | Embryo selection through non-invasive preimplantation genetic testing with cell-free DNA in spent culture media: a protocol for a multicentre, double-blind, randomised controlled trial |
| title_fullStr | Embryo selection through non-invasive preimplantation genetic testing with cell-free DNA in spent culture media: a protocol for a multicentre, double-blind, randomised controlled trial |
| title_full_unstemmed | Embryo selection through non-invasive preimplantation genetic testing with cell-free DNA in spent culture media: a protocol for a multicentre, double-blind, randomised controlled trial |
| title_short | Embryo selection through non-invasive preimplantation genetic testing with cell-free DNA in spent culture media: a protocol for a multicentre, double-blind, randomised controlled trial |
| title_sort | embryo selection through non invasive preimplantation genetic testing with cell free dna in spent culture media a protocol for a multicentre double blind randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/7/e057254.full |
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