Using Preimplantation Genetic Diagnosis in Autosomal Dominant Polycystic Kidney Disease Patients: a Multicenter Clinical Trial
NCT ID: NCT02948179
Last Updated: 2021-01-26
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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COMPLETED
NA
459 participants
INTERVENTIONAL
2016-09-02
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Preimplantation genetic diagnosis group
ADPKD patients will complete the whole process of preimplantation genetic diagnosis with healthy baby without pathogenic gene inheritance.
Preimplantation Genetic Diagnosis
Using Preimplantation genetic diagnosis, including multiple annealing and looping-based amplification cycles amplification technique, the investigators have had screened out healthy embryos by In Vitro Fertilization. Then the investigators transplanted embryos returned to the parent. Finally, participants will have healthy baby without pathogenic gene inheritance.
Natural pregnancy group
ADPKD patients, pathogenic mutations in PKD1, have natural pregnancy without preimplantation genetic diagnosis.The investigators will perform genetic tests on the blood or umbilical cord blood of infants born between January 2014 and June 2020.
No interventions assigned to this group
Interventions
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Preimplantation Genetic Diagnosis
Using Preimplantation genetic diagnosis, including multiple annealing and looping-based amplification cycles amplification technique, the investigators have had screened out healthy embryos by In Vitro Fertilization. Then the investigators transplanted embryos returned to the parent. Finally, participants will have healthy baby without pathogenic gene inheritance.
Eligibility Criteria
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Inclusion Criteria
* Wife has age limitation from 20 years to 35 years
* ADPKD ADPKD diagnosis with or without family history
* Find out specific pathogenic mutations in the PKD1 gene with at least one of the following: one of family patients done kidney transplantation or renal replacement therapy before 58 years old; one of family patients died of complications before 55 years old; the patient with total kidney volume more than 650ml; the patient with total kidney volume increase rate more than 6% every year; the patient's PKD1 mutation belongs to truncated gene mutation.
* Both husband and wife have assisted reproductive conditions and will
* Pregnancy compliance with Chinese laws
* Signed informed consent
Exclusion Criteria
* Any one of the couple has used any drugs which may lead to abnormal reproductive system function, reproductive cell abnormalities, pregnancy risk increases in the past 3 months, or has history of drug abuse
* Any one of the couple has malignancy
* The wife has uncontrolled hypertension or refractory hypertension
* The wife has diabetes mellitus
* The wife has albuminuria
* The wife has autoimmune disease
* The wife has other disorders or functional abnormalities, such as liver or renal dysfunction, which may be aggravated by pregnancy or assisted reproduction
* Allergy to drugs or related products which cannot avoid in our study
* Participating in other clinical studies in last 3 months
* Participants cannot follow the study program
* Other conditions that the researchers considered unsuitable for participation
20 Years
35 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Anhui Medical University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Shandong Provincial Hospital
OTHER_GOV
Tang-Du Hospital
OTHER
Shengjing Hospital
OTHER
Second Xiangya Hospital of Central South University
OTHER
Reproductive & Genetic Hospital of CITIC-Xiangya
OTHER
Peking University Third Hospital
OTHER
Navy General Hospital, Beijing
OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
The First Affiliated Hospital of Soochow University
OTHER
Sir Run Run Shaw Hospital
OTHER
Fuzhou General Hospital
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Wuhan TongJi Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Renmin Hospital of Wuhan University
OTHER
Xiangya Hospital of Central South University
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Southwest Hospital, China
OTHER
LanZhou University
OTHER
Shaanxi Provincial People's Hospital
OTHER
West China Hospital
OTHER
West China Second University Hospital
OTHER
Sichuan Provincial People's Hospital
OTHER
Hebei Medical University Third Hospital
OTHER
Hebei Province Center for Reproductive Medicine
UNKNOWN
The Second Hospital of Hebei Medical University
OTHER
Hospital for Reproductive Medicine Affiliated to Shandong University
UNKNOWN
Changlin Mei
OTHER
Responsible Party
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Changlin Mei
Professor, Director of kidney Institute
Principal Investigators
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changlin Mei, Master
Role: PRINCIPAL_INVESTIGATOR
Institute of Nephrology, Changzheng Hospital
wen Li, doctor
Role: PRINCIPAL_INVESTIGATOR
Center of Reproductive Medicine, Changzheng Hospital
Locations
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Navy General Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Southwest Hospital
Chongqing, Chongqing Municipality, China
Fuzhou General Hospital
Fuzhou, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Hebei Province Center for Reproductive Medicine
Shijiazhuang, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Wuhan Tongji Hospital
Wuhan, Hubei, China
Wuhan Union Hospital
Wuhan, Hubei, China
Reproductive & Genetic Hospital of CITIC-Xiangya
Changsha, Hunan, China
Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Shengjing Hospital
Shenyang, Liaoning, China
Hospital for Reproductive Medicine Affiliated to Shandong University
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
Tang-Du Hospital
Xi’an, Shanxi, China
Shanxi Provincial People's Hospital
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
West China Second University Hospital
Chengdu, Sichuan, China
Sir Run Run Shaw Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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CZKIPLA-ADPKD-003
Identifier Type: -
Identifier Source: org_study_id
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