Using Preimplantation Genetic Diagnosis in Autosomal Dominant Polycystic Kidney Disease Patients: a Multicenter Clinical Trial (ESPERANCE)
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|ClinicalTrials.gov Identifier: NCT02948179|
Recruitment Status : Recruiting
First Posted : October 28, 2016
Last Update Posted : December 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Kidney, Type 1 Autosomal Dominant Disease||Procedure: Preimplantation Genetic Diagnosis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Preimplantation Genetic Diagnosis in Blocking Pathogenic Gene Inheritance for Autosomal Dominant Polycystic Kidney Disease: a Multicenter Clinical Trial|
|Actual Study Start Date :||September 2, 2016|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Preimplantation genetic diagnosis group
ADPKD patients will complete the whole process of preimplantation genetic diagnosis with healthy baby without pathogenic gene inheritance.
Procedure: 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.
No Intervention: 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.
- Healthy baby Rate without pathogenic gene inheritance [ Time Frame: through study completion, an average of 2 year ]The investigators will do umbilical cord blood gene detection for the baby to confirm with or without pathogenic gene inheritance. The investigators will compare two groups of healthy newborns rate.
- Success rate in pretest of preimplantation genetic diagnosis [ Time Frame: through study completion, an average of 2 year ]Using couples blood to do pretest of preimplantation genetic diagnosis in Peripheral blood mononuclear lymphocyte.
- Technical failure rate of preimplantation genetic diagnosis. [ Time Frame: Amniotic fluid puncture test (pregnancy 16 to 19 weeks ) and Birth day ]The rate of amniotic fluid puncture test or umbilical cord blood gene detection confirm the offspring containing pathogenic gene mutation.
- Oocyte retrieval rate [ Time Frame: through study completion, an average of 2 years ]The proportion of good eggs obtained after ovulation induction
- Good quality embryo rate [ Time Frame: through study completion, an average of 2 years ]The well-developed blastocyst ratio obtained after intracytoplasmic sperm injection
- Pregnancy rate [ Time Frame: Four weeks after embryo transplantation ]Successful pregnancy rate of transplanted embryo
- Take home baby rate [ Time Frame: Two week after neonatus birth day ]Healthy newborn birth rate in preimplantation genetic diagnosis group
- The total kidney volume change rate [ Time Frame: From enroll to postpartum 6 months ]The investigators do twice kidney MRI scan for calculating total kidney volume change rate between enroll and postpartum 6 months.
- The estimated glomerular filtration rate change [ Time Frame: From enroll to postpartum 6 months ]The investigators do twice serum creatinine test between enroll and postpartum 6 months, then using CKD-EPI formula to calculate eGFR.
- The incidence of ovarian hyperstimulation syndrome [ Time Frame: through study completion, an average of 2 years ]the incidence of ovarian hyperstimulation syndrome
- The incidence of organ injuries [ Time Frame: through study completion, an average of 2 years ]the incidence of organ injuries
- The incidence of infection [ Time Frame: through study completion, an average of 2 years ]the incidence of infection
- The incidence of abortion rate [ Time Frame: through study completion, an average of 2 years ]the incidence of abortion rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948179
|Contact: Yiyi Ma, firstname.lastname@example.org|
|Contact: Bo Yang, email@example.com|
Show 31 Study Locations
|Principal Investigator:||changlin Mei, Master||Institute of Nephrology, Changzheng Hospital|
|Principal Investigator:||wen Li, doctor||Center of Reproductive Medicine, Changzheng Hospital|