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A pilot cohort study of autologous platelet-rich plasma in the treatment of unresponsive thin endometrium resistant to standard therapies

Status Approved

  • First Submitted Date

    2018/10/17

  • Registered Date

    2018/12/07

  • Last Updated Date

    2018/11/09

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003385
    Unique Protocol ID BDCHA R&D 2015-47
    Public/Brief Title Autologous PRP treatment for refractory thin endometrium to enhance pregnancy and live birth rate
    Scientific Title A pilot cohort study of autologous platelet-rich plasma in the treatment of unresponsive thin endometrium resistant to standard therapies
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number BD2015-181
    Approval Date 2015-12-22
    Institutional Review Board Name Institutional Review Board, CHA Bundang Medical Center, CHA University
    Institutional Review Board Address 59, Yatap-ro, Bundang-gu, Seongnam-si, Gyeonggi-do
    Institutional Review Board Telephone 031-780-5314
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Ji Hyang Kim
    Title assist professor
    Telephone +82-31-780-5200
    Affiliation Bundang CHA General Hospital
    Address CHA Bundang Medical Center, 59 Yatap-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 13496, Korea
    Contact Person for Public Queries
    Name Hounyoung Kim
    Title Fellow
    Telephone +82-31-780-5200
    Affiliation Bundang CHA General Hospital
    Address CHA Bundang Medical Center, 59 Yatap-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 13496, Korea
    Contact Person for Updating Information
    Name Ji Hyang Kim
    Title assist professor
    Telephone +82-31-780-5200
    Affiliation Bundang CHA General Hospital
    Address CHA Bundang Medical Center, 59 Yatap-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 13496, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2016-01-11 Actual
    Target Number of Participant 100
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Bundang CHA General Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2016-01-11 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Bundang CHA General Hospital
    Organization Type Medical Institute
    Project ID BDCHA R&D 2015-47
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Bundang CHA General Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Endometrium thickness is one of key factors for implantation of embryo. The empirical preference for endometrial thickness among clinicians is ET>7mm, and the refractory thin endometrium, which doesn’t respond to standard medical therapies, can be the etiology of recurrent implantation failure (RIF). To evaluate the effect of autologous platelet rich plasma on treating refractory thin endometrium, a prospective cohort study was designed. Women who had a history of two or more failed IVF cycles and refractory thin endometrium were enrolled in this study. The main inclusion criteria were EMT of < 7 mm after more than 2 cycles of previous medical therapy for increasing the EMT.  The subjects will be treated with intrauterine infusion of autologous PRP 2 or 3 times from menstrual cycle day 10 of their frozen-thawed embryo transfer (FET) cycle, and ET will be performed 3 days after the final autologous PRP infusion. After 2 weeks, b-hCG test will be done and for those who had positive result will go under sonography to confirm G-sac. Thereafter until the delivery, timelt chart review will be done.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Single Group  
    Blinding/Masking Open
    Allocation Non-RCT
    Intervention Type /Biological/Vaccine, /Non-Stem Cell  
    Intervention Description
    The subjects were treated with intrauterine infusion of autologous Platelet rich plasma (PRP) 2 or 3 times from menstrual cycle day 10 of their frozen-thawed embryo transfer (FET) cycle, and ET was performed 3 days after the final autologous PRP infusion. The 0.5ml ~ 1ml of PRP was made with 20ml of  patient own blood by centrofuge and was used within 1 hour.
    Number of Arms 1
    Arm 1

    Arm Label

    Women who had a history of two or more failed IVF cycles and refractory thin endometrium < 7mm.

    Target Number of Participant

    100

    Arm Type

    Experimental

    Arm Description

    The subjects were treated with intrauterine infusion of autologous Platelet rich plasma (PRP) 2 or 3 times from menstrual cycle day 10 of their frozen-thawed embryo transfer (FET) cycle, and ET was performed 3 days after the final autologous PRP infusion. The 0.5ml ~ 1ml of PRP was made with 20ml of  patient own blood by centrofuge and was used within 1 hour.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (N00-N99)Diseases of the genitourinary system 
       (N97.2)Female infertility of uterine origin 
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    20Year~45Year

    Description

    (a) age of 20‒45 years at the time of enrollment, (b) endometrial thickness (EMT) of <7 mm on the human chorionic gonadotropin (hCG) administration day in fresh ET cycles or on the end of estrogen priming day in frozen ET cycles in all of the previous cycles, (c) two or more failed IVF cycles, (d) more than two cycles of previous therapy for increasing the EMT, such as, hysteroscopic adhesiolysis following hormone replacement therapy, high dose estradiol valerate, transvaginal sildenafil administration, or pentoxifyilline combination with vitamin E, (e) frozen embryo available for ET, and (f) informed consent form signed.
    Exclusion Criteria
    (a) hematologic disorders, hemoglobin level of <9.0 g/dL or platelet count of <100,000/μL, (b) auto-immune disease, (c) chromosomal abnormality in the patient or spouse, (d) peripheral NK cell proportion of ≥12%, (e) body mass index (BMI) of ≥30 kg/m2, and (f) uncontrolled endocrine or other medical conditions, such as prolactinemia or thyroid diseases
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Live birth rate
    Timepoint
    delivery day
    Secondary Outcome(s) 1
    Outcome
    clinical pregnancy day
    Timepoint
    obsteteric sonography day
    Secondary Outcome(s) 2
    Outcome
    Emdometrial thickness increment
    Timepoint
    last day of platelet rich plasa treatment day
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration
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