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Cumulative Live Birth Rate With eSET After Preimplantation Genetic Screening Versus Conventional In-vitro Fertilization (CESE-PGS)

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ClinicalTrials.gov Identifier: NCT03118141
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : September 20, 2019
Sponsor:
Collaborators:
The First Affiliated Hospital with Nanjing Medical University
Peking University Third Hospital
ShangHai Ji Ai Genetics & IVF Institute
RenJi Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Suzhou Municipal Hospital
Renmin Hospital of Wuhan University
Yantai Yuhuangding Hospital
Tang-Du Hospital
Nanjing Maternity and Child Health Care Hospital
Guangxi Maternal and Child Health Hospital
Women's Hospital School Of Medicine Zhejiang University
Guangdong Women and Children Hospital
Tianjin Central Hospital of Gynecology Obstetrics
Shengjing Hospital
The First Affiliated Hospital of Anhui Medical University
Information provided by (Responsible Party):
Chen Zi-Jiang, Shandong University

Tracking Information
First Submitted Date  ICMJE March 27, 2017
First Posted Date  ICMJE April 18, 2017
Last Update Posted Date September 20, 2019
Actual Study Start Date  ICMJE July 9, 2017
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2017)
Cumulative live birth rate [ Time Frame: 22 months ]
Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation after our interventions, and cumulative live birth rate is calculated by dividing the number of women achieving live birth after transfers of all study-specific embryos (up to 3 transfers of single blastocycst within 1 year after randomization), by the total number of women randomized to the specific group.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2017)
  • Rate of Good Birth Outcomes [ Time Frame: 22 months ]
    Number of good birth outcomes / number of clinical pregnancies over (up to) 3 transfers within 1 year.Good Birth Outcome is defined as live birth of an infant born at ≥ 37 weeks, with a birth weight between 2500 and 4000g and without a major congenital anomaly.
  • Cumulative pregnancy rate [ Time Frame: 14 months ]
    Number of women with clinical pregnancies over (up to) 3 transfers within 1 year / number of women randomized to the specific group. Clinical pregnancy will be diagnosed with detection of an intrauterine gestational sac.
  • Cumulative pregnancy loss rate [ Time Frame: 19 months ]
    Number of pregnancy losses / number of clinical pregnancies over (up to) 3 transfers within 1 year.Pregnancy loss refers to a complete spontaneous abortion or a nonviable pregnancy before 28 weeks of gestation.
  • Multiple pregnancy rate [ Time Frame: 22 months ]
    Number of multiple pregnancies / number of clinical pregnancies over (up to) 3 transfers within 1 year.
  • Duration of pregnancy [ Time Frame: 22 months ]
    The time from the first day of last menstrual period to the day of delivery.
  • Birth weight [ Time Frame: 22 months ]
    Weight of newborns at delivery.
  • Cumulative incidence of maternal and neonatal complications during whole gestation and prenatal stage [ Time Frame: 22 months ]
    Number of pregnancies with complications / number of pregnancies over (up to) 3 transfers within 1 year;number of live births with neonatal complications / number of live births over (up to)3 transfers within 1 year.
  • Number of embryo transfers to achieve live birth [ Time Frame: 22 months ]
    Number of embryo transfers the patients have gone through to achieve live birth.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 12, 2017)
  • Clinical pregnancy rate after the first transfer [ Time Frame: 4 months ]
    Number of women with clinical pregnancies after the first transfer / number of women randomized to the specific group.
  • Pregnancy loss rate after the first transfer [ Time Frame: 9 months ]
    Number of pregnancy losses / number of clinical pregnancies after the first transfer .
  • Live birth rate after the first transfer [ Time Frame: 12 months ]
    Number of women with live births after the first transfer / number of women randomized to the specific group.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Cumulative Live Birth Rate With eSET After Preimplantation Genetic Screening Versus Conventional In-vitro Fertilization
Official Title  ICMJE Cumulative Live Birth Rate With eSET After In-vitro Fertilization With Preim-plantation Genetic Screening by Next Generation Sequencing Versus Conventional In-vitro Fertilization: A Pragmatic Randomized Controlled Clinical Trial
Brief Summary The purpose of this randomized clinical trial is to compare the efficacy and safety with transfer of embryos selected by next generation sequencing (NGS) versus conventional morphological criteria. Subjects with 3 or more blastocysts on day 5 of embryo culture will be randomized to the PGS or IVF group. A Freeze-all strategy and a single frozen blastocyst transfer will be performed in both PGS and IVF groups. The primary outcome is the cumulative live birth after transfers of up to 3 single blastocycsts in both groups.
Detailed Description This is a multicenter, randomized clinical trial comparing the efficacy and safety with transfer of embryos selected by next generation sequence (NGS) and morphologic criteria versus by morphological criteria alone. Subjects who obtain 3 or more good-quality blastocysts will be randomized to PGS or IVF group. All embryos will be frozen and a single thawed blastocyst will be transferred in both PGS and IVF group. Subjects in the PGS group will have 3 blastocysts sequenced and euploid embryos will be subsequently transferred. Subjects in the IVF group will have blastocysts selected by morphology assessment. The cumulative live birth rate will be counted after transfers of all euploid embryo in the PGS group and 3 blastocysts in the IVF group within 1 year after randomization.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE
  • Procedure: blastocyst morphologic score
    Blastocysts will be scored by Gardner morphologic criteria.
  • Procedure: blastocyst biopsy and sequencing
    Three blastocysts will be biopsied on trophectoderm, sequenced with next-generation sequencing (NGS). Euploidy will transferred one by one according to morphologic score.
  • Procedure: freeze-all and single thawed blastocyst transfer
    All blastocysts will be vitrified in fresh cycle. Single blastocyst will be thawed and transferred.
Study Arms  ICMJE
  • Active Comparator: PGS group
    Subjects in the PGS group will have blastocyst biopsy and sequencing done with 3 good-quality embryos on Day 5. Principle of freeze-all and single thawed blastocyst transfer will be applied. The transfer order of euploid embryos will be determined by blastocyst morphologic score. The outcome of all euploids transfers within 1 year after randomization will be followed up. During study, every subject will have at most one live birth.
    Interventions:
    • Procedure: blastocyst morphologic score
    • Procedure: blastocyst biopsy and sequencing
    • Procedure: freeze-all and single thawed blastocyst transfer
  • Active Comparator: IVF group
    Subjects in the IVF group will also comply with the principle of freeze-all and single thawed blastocyst transfer. The order of transfer will be determined by blastocyst morphologic score. The outcome of up to 3 transfers within 1 year after randomization will be followed up. During study, every subject will have at most one live birth.
    Interventions:
    • Procedure: blastocyst morphologic score
    • Procedure: freeze-all and single thawed blastocyst transfer
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2019)
1215
Original Estimated Enrollment  ICMJE
 (submitted: April 12, 2017)
1208
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Women who are participating in their first cycle of IVF or ICSI
  2. Women ages 20 to 37 years.
  3. Women who obtain 3 or more good-quality blastocysts 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 will be randomized.

Exclusion Criteria:

  1. Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus uni-cornate, bicornate, or duplex); untreated uterine septum, adenomyosis, submucous myoma, or endo-metrial polyp(s); or with history of intrauterine adhesions.
  2. Women with untreated hydrosalpinx;
  3. Women who are indicated and planned to undergo PGD, for example, parental abnormal karyo-type or diagnosed with monogenic disease;
  4. Women who use donated oocytes or sperm to achieve pregnancy;
  5. 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 se-rum liver enzyme testing); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; uncontrolled hyper-tension, known symptomatic heart disease; history of or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma; undiagnosed vaginal bleeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 37 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zi-Jiang Chen, Professor +0086 531 85651190 chenzijiang@vip.163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03118141
Other Study ID Numbers  ICMJE CESE-PGS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Chen Zi-Jiang, Shandong University
Study Sponsor  ICMJE Chen Zi-Jiang
Collaborators  ICMJE
  • The First Affiliated Hospital with Nanjing Medical University
  • Peking University Third Hospital
  • ShangHai Ji Ai Genetics & IVF Institute
  • RenJi Hospital
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • Suzhou Municipal Hospital
  • Renmin Hospital of Wuhan University
  • Yantai Yuhuangding Hospital
  • Tang-Du Hospital
  • Nanjing Maternity and Child Health Care Hospital
  • Guangxi Maternal and Child Health Hospital
  • Women's Hospital School Of Medicine Zhejiang University
  • Guangdong Women and Children Hospital
  • Tianjin Central Hospital of Gynecology Obstetrics
  • Shengjing Hospital
  • The First Affiliated Hospital of Anhui Medical University
Investigators  ICMJE Not Provided
PRS Account Shandong University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP