First Live Birth Rate With eSET After Preimplantation Methylome Screening (PIMS) Versus Conventional In-vitro Fertilization
NCT ID: NCT05442125
Last Updated: 2024-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1146 participants
INTERVENTIONAL
2022-09-16
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PIMS group
Couples in the PIMS group will have up to 6 blastocysts screened with PIMS and a single euploid embryo with the optimal state of whole-genome DNA methylation and the highest morphologic score will be selected for the initial transfer. The optimal state of whole-genome DNA methylation includes methylation level closest to the optimal level (0.26 according to our preliminary results) and proper methylation state for some specific regions.
Using DNA methylome to select embryos
DNA methylation level Embryo with methylation level closest to the optimal level (from one couple patients) is the one for embryonic transfer to uterus
Conventional-IVF group
For women between 20 and 37 years of age,couples in the conventional-IVF group will have a single best blastocyst by morphologic criteria selected for the initial transfer.For women over 37 years old, couples in the PGT-A group will have up to 6 blastocysts tested with PGT-A and a single euploid embryo with the highest morphologic score will be selected for the initial transfer.
Using morphologic score to select embryos
blastocyst will transferred according to morphologic score or blastocysts will be biopsied on trophectoderm, sequenced with next-generation sequencing (NGS). Euploidy will transferred one by one according to morphologic score.
Interventions
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Using DNA methylome to select embryos
DNA methylation level Embryo with methylation level closest to the optimal level (from one couple patients) is the one for embryonic transfer to uterus
Using morphologic score to select embryos
blastocyst will transferred according to morphologic score or blastocysts will be biopsied on trophectoderm, sequenced with next-generation sequencing (NGS). Euploidy will transferred one by one according to morphologic score.
Eligibility Criteria
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Inclusion Criteria
2. Women aged 20 years and older.
b) Women who obtain 2 or more good-quality blastocysts that defined as morphological score of inner cell mass B or A, trophectoderm C or better, and grade 4 or better on Day 5 of embryo culture.
Exclusion Criteria
2. Women who are indicated and planned to undergo preimplantation genetic testing for structural rearrangements (PGT-SR) or preimplantation genetic testing for monogenic (PGT-M).
3. Women who use donated oocytes or sperm to achieve pregnancy;
4. Women with contraindication for assisted reproductive technology or for pregnancy, such as poorly controlled Type I or Type II diabetes; undiagnosed liver disease or dysfunction (based on serum liver enzyme testing); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; uncontrolled hypertension, known symptomatic heart disease; history of or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma; undiagnosed vaginal bleeding.
20 Years
FEMALE
Yes
Sponsors
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RenJi Hospital
OTHER
Reproductive & Genetic Hospital of CITIC-Xiangya
OTHER
Nanjing Maternity and Child Health Care Hospital
OTHER
ShangHai Ji Ai Genetics & IVF Institute
OTHER
Suzhou Municipal Hospital
OTHER
The First Hospital of Jilin University
OTHER
Sir Run Run Shaw Hospital
OTHER
The Affiliated Hospital Of Guizhou Medical University
OTHER
The Second Hospital of Hebei Medical University
OTHER
Third Affiliated Hospital of Zhengzhou University
OTHER
Ruijin Hospital
OTHER
International Peace Maternity and Child Health Hospital
OTHER
Henan Provincial People's Hospital
OTHER
The First Affiliated Hospital of Hainan Medical University
OTHER_GOV
The First Affiliated Hospital of Anhui Medical University
OTHER
Fujian Maternity and Child Health Hospital
OTHER
General Hospital of Ningxia Medical University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
900 Hospital of Joint Logistics Support Force of PLA
OTHER
Guangzhou Womenand Children's Medical Center
UNKNOWN
Changhai Hospital
OTHER
Shenzhen Maternity & Child Healthcare Hospital
OTHER
Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Liuzhou Hospital of Guangzhou Women and Children's Medical Center
UNKNOWN
Jining Medical University
OTHER
Siriraj Hospital
OTHER
Shandong University
OTHER
Responsible Party
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Chen Zi-Jiang
Academician
Principal Investigators
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Yuan Gao, Professor
Role: STUDY_DIRECTOR
Center for Reproductive Medicine, Shandong University
Yun Sun, Professor
Role: PRINCIPAL_INVESTIGATOR
Center for Reproductive Medicine, Ren Ji Hospital, School of Medicine,Shanghai Jiao Tong University
Ge Lin, Professor
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Center for Reproduction and Genetics in Hunan Province, Reproductive and Genetic Hospital of CITIC-XIANGYA
Xiufeng Ling, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Reproductive Medicine, Women's Hospital of Nanjing Medical University, Nanjing Maternity and Child Health Care Hospital
Xiaoxi Sun, Professor
Role: PRINCIPAL_INVESTIGATOR
Shanghai Ji Ai Genetics and IVF Institute, Obstetrics and Gynecology Hospital, Fudan University
Hong Li, Professor
Role: PRINCIPAL_INVESTIGATOR
Center for reproduction and genetics,suzhou municipal hospital
Ruizhi Liu, Professor
Role: PRINCIPAL_INVESTIGATOR
Center for Reproductive Medicine, Center for Prenatal Diagnosis First Hospital, Jilin University
Songying Zhang, Professor
Role: PRINCIPAL_INVESTIGATOR
Assisted Reproduction Unit, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Shuyun Zhao, Professor
Role: PRINCIPAL_INVESTIGATOR
Center for Reproductive Medicine, The Affiliated Hospital of Guizhou Medical University
Guimin Hao, Professor
Role: PRINCIPAL_INVESTIGATOR
The Second Hospital of Hebei Medical University
Yichun Guan, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Reproductive Medicine, the Third Affiliated Hospital of Zhengzhou University
Aijun Zhang, Professor
Role: PRINCIPAL_INVESTIGATOR
Reproductive Medical Center of Ruijin Hospital, School of Medicine,Shanghai Jiao Tong University
Wen Li, Professor
Role: PRINCIPAL_INVESTIGATOR
International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University
Cuilian Zhang, Professor
Role: PRINCIPAL_INVESTIGATOR
Reproductive Medical Center, Henan Provincial People's Hospital
Yanlin Ma, Professor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Hainan Medical University
Yunxia Cao, Professor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Anhui Medical University
Beihong Zhen, Professor
Role: PRINCIPAL_INVESTIGATOR
Fujian Maternity and Child Health Hospital College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University
Junli Zhao, Professor
Role: PRINCIPAL_INVESTIGATOR
The General Hospital of Ningxia Medical University
Xiang Ma, Professor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Yun Liu, Professor
Role: PRINCIPAL_INVESTIGATOR
900 Hospital of Joint Logistics Support Force of PLA
Ling Sun, Professor
Role: PRINCIPAL_INVESTIGATOR
Guangzhou Womenand Children's Medical Center
Hongli Yan, Professor
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital
Xuemei Li, Professor
Role: PRINCIPAL_INVESTIGATOR
Shenzhen Maternity & Child Healthcare Hospital
Haitao Zeng, Professor
Role: PRINCIPAL_INVESTIGATOR
Sixth Affiliated Hospital, Sun Yat-sen University
Li Fan, Professor
Role: PRINCIPAL_INVESTIGATOR
Liuzhou Hospital of Guangzhou Women and Children's Medical Center
Aijun Yang, Professor
Role: PRINCIPAL_INVESTIGATOR
Jining Medical University
Isarin Thanaboonyawat, Doctor
Role: PRINCIPAL_INVESTIGATOR
Siriraj Hospital
Locations
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Shandong University
Jinan, Shandong, China
Center for Reproductive Medicine, Center for Prenatal Diagnosis First Hospital, Jilin University
Changchun, , China
Clinical Research Center for Reproduction and Genetics in Hunan Province, Reproductive and Genetic Hospital of CITIC-XIANGYA
Changsha, , China
900 th Hospital of Joint Logistics Support Force
Fuzhou, , China
Fujian Maternity and Child Health Hospital College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University
Fuzhou, , China
Guangzhou Womenand Children's Medical Center
Guanzhou, , China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guanzhou, , China
Center for Reproductive Medicine, The Affiliated Hospital of Guizhou Medical University
Guiyang, , China
The first affiliated hospital of Hainan Medical University
Haikou, , China
Assisted Reproduction Unit, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, , China
The First Affiliated Hospital of Anhui Medical University
Hefei, , China
Center for Reproductive Medicine, Shandong University
Jinan, , China
Affiliated Hospital of Jining Medical University
Jining, , China
Liuzhou Hospital of Guangzhou Women and Children's Medical Center
Liuzhou, , China
Department of Reproductive Medicine, Women's Hospital of Nanjing Medical University, Nanjing Maternity and Child Health Care Hospital
Nanjing, , China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, , China
Center for Reproductive Medicine, Ren Ji Hospital, School of Medicine,Shanghai Jiao Tong University
Shanghai, , China
Changhai Hospital
Shanghai, , China
International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, , China
Reproductive Medical Center of Ruijin Hospital, School of Medicine,Shanghai Jiao Tong University
Shanghai, , China
Shanghai Ji Ai Genetics and IVF Institute, Obstetrics and Gynecology Hospital, Fudan University
Shanghai, , China
Shenzhen Maternity & Child Healthcare Hospital
Shenzhen, , China
The Second Hospital of Hebei Medical University
Shijiazhuang, , China
Center for reproduction and genetics,suzhou municipal hospital
Suzhou, , China
The General Hospital of Ningxia Medical University
Yinchuan, , China
Department of Reproductive Medicine, the Third Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Reproductive Medical Center, Henan Provincial People's Hospital
Zhengzhou, , China
Siriraj hospital, Mahidol university
Bangkok, , Thailand
Countries
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Central Contacts
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Facility Contacts
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Ruizhi Liu, Professor
Role: primary
Lin Ge, Professor
Role: primary
Yun Liu, Professor
Role: primary
Beihong Zhen, Professor
Role: primary
Ling Sun, Professor
Role: primary
Haitao Zeng, Professor
Role: primary
Shunyun Zhao, Professor
Role: primary
Yanlin Ma, Professor
Role: primary
Songying Zhang, Professor
Role: primary
Yunxia Cao, Professor
Role: primary
Yuan Gao, Professor
Role: primary
Aijun Yang, Professor
Role: primary
Li Fan, Professor
Role: primary
Xiufeng Ling, Professor
Role: primary
Xiang Ma, Professor
Role: primary
Yun Sun, Professor
Role: primary
Hongli Yan, Professor
Role: primary
Wen Li, Professor
Role: primary
Aijun Zhang, Professor
Role: primary
Xiaoxi Sun, Professor
Role: primary
Xuemei Li, Professor
Role: primary
Guimin Hao, Professor
Role: primary
Hong Li, Professor
Role: primary
Junli Zhao, Professor
Role: primary
Yichun Guan, Professor
Role: primary
Cuilian Zhang, Professor
Role: primary
Isarin Thanaboonyawat, Doctor
Role: primary
References
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Brezina PR, Kutteh WH. Clinical applications of preimplantation genetic testing. BMJ. 2015 Feb 19;350:g7611. doi: 10.1136/bmj.g7611.
Hassold T, Chen N, Funkhouser J, Jooss T, Manuel B, Matsuura J, Matsuyama A, Wilson C, Yamane JA, Jacobs PA. A cytogenetic study of 1000 spontaneous abortions. Ann Hum Genet. 1980 Oct;44(2):151-78. doi: 10.1111/j.1469-1809.1980.tb00955.x.
Dahdouh EM, Balayla J, Audibert F; Genetics Committee; Wilson RD, Audibert F, Brock JA, Campagnolo C, Carroll J, Chong K, Gagnon A, Johnson JA, MacDonald W, Okun N, Pastuck M, Vallee-Pouliot K. RETIRED: Technical Update: Preimplantation Genetic Diagnosis and Screening. J Obstet Gynaecol Can. 2015 May;37(5):451-63. doi: 10.1016/s1701-2163(15)30261-9.
Kalousek DK, Pantzar T, Tsai M, Paradice B. Early spontaneous abortion: morphologic and karyotypic findings in 3,912 cases. Birth Defects Orig Artic Ser. 1993;29(1):53-61. No abstract available.
Rubio C, Bellver J, Rodrigo L, Castillon G, Guillen A, Vidal C, Giles J, Ferrando M, Cabanillas S, Remohi J, Pellicer A, Simon C. In vitro fertilization with preimplantation genetic diagnosis for aneuploidies in advanced maternal age: a randomized, controlled study. Fertil Steril. 2017 May;107(5):1122-1129. doi: 10.1016/j.fertnstert.2017.03.011. Epub 2017 Apr 19.
Sacchi L, Albani E, Cesana A, Smeraldi A, Parini V, Fabiani M, Poli M, Capalbo A, Levi-Setti PE. Preimplantation Genetic Testing for Aneuploidy Improves Clinical, Gestational, and Neonatal Outcomes in Advanced Maternal Age Patients Without Compromising Cumulative Live-Birth Rate. J Assist Reprod Genet. 2019 Dec;36(12):2493-2504. doi: 10.1007/s10815-019-01609-4. Epub 2019 Nov 12.
Yan J, Qin Y, Zhao H, Sun Y, Gong F, Li R, Sun X, Ling X, Li H, Hao C, Tan J, Yang J, Zhu Y, Liu F, Chen D, Wei D, Lu J, Ni T, Zhou W, Wu K, Gao Y, Shi Y, Lu Y, Zhang T, Wu W, Ma X, Ma H, Fu J, Zhang J, Meng Q, Zhang H, Legro RS, Chen ZJ. Live Birth with or without Preimplantation Genetic Testing for Aneuploidy. N Engl J Med. 2021 Nov 25;385(22):2047-2058. doi: 10.1056/NEJMoa2103613.
Smith ZD, Meissner A. DNA methylation: roles in mammalian development. Nat Rev Genet. 2013 Mar;14(3):204-20. doi: 10.1038/nrg3354. Epub 2013 Feb 12.
Jones PA. Functions of DNA methylation: islands, start sites, gene bodies and beyond. Nat Rev Genet. 2012 May 29;13(7):484-92. doi: 10.1038/nrg3230.
Jiang L, Zhang J, Wang JJ, Wang L, Zhang L, Li G, Yang X, Ma X, Sun X, Cai J, Zhang J, Huang X, Yu M, Wang X, Liu F, Wu CI, He C, Zhang B, Ci W, Liu J. Sperm, but not oocyte, DNA methylome is inherited by zebrafish early embryos. Cell. 2013 May 9;153(4):773-84. doi: 10.1016/j.cell.2013.04.041.
Li G, Yu Y, Fan Y, Li C, Xu X, Duan J, Li R, Kang X, Ma X, Chen X, Ke Y, Yan J, Lian Y, Liu P, Zhao Y, Zhao H, Chen Y, Sun X, Liu J, Qiao J, Liu J. Genome wide abnormal DNA methylome of human blastocyst in assisted reproductive technology. J Genet Genomics. 2017 Oct 20;44(10):475-481. doi: 10.1016/j.jgg.2017.09.001. Epub 2017 Sep 6.
Hardarson T, Van Landuyt L, Jones G. The blastocyst. Hum Reprod. 2012 Aug;27 Suppl 1:i72-91. doi: 10.1093/humrep/des230. Epub 2012 Jul 3. No abstract available.
Schieve LA, Meikle SF, Peterson HB, Jeng G, Burnett NM, Wilcox LS. Does assisted hatching pose a risk for monozygotic twinning in pregnancies conceived through in vitro fertilization? Fertil Steril. 2000 Aug;74(2):288-94. doi: 10.1016/s0015-0282(00)00602-6.
Fiorentino F, Biricik A, Bono S, Spizzichino L, Cotroneo E, Cottone G, Kokocinski F, Michel CE. Development and validation of a next-generation sequencing-based protocol for 24-chromosome aneuploidy screening of embryos. Fertil Steril. 2014 May;101(5):1375-82. doi: 10.1016/j.fertnstert.2014.01.051. Epub 2014 Mar 6.
Other Identifiers
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PIMS-IVF
Identifier Type: -
Identifier Source: org_study_id
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