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PRP Prevents Recurrence of Intrauterine Adhesions (RPR-IUAs)

Primary Purpose

Intrauterine Adhesion

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Platelet-rich plasma
gel
Sponsored by
Yanhong Deng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intrauterine Adhesion

Eligibility Criteria

20 Years - 37 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:Patients with intrauterine adhesions (AFS score >9 points); age 21 to 40 years old, with fertility requirements -

Exclusion Criteria:Endometrial tuberculosis, endometrial polyps, uterine submucosal fibroids, endometrial hyperplasia, endometrial malignant lesions, premature ovarian failure, chromosomal abnormalities

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    PRP

    Gel

    Arm Description

    Platelet-rich plasma

    Self-crosslinking sodium hyaluronate gel

    Outcomes

    Primary Outcome Measures

    AFS score
    AFS score

    Secondary Outcome Measures

    Full Information

    First Posted
    August 9, 2018
    Last Updated
    August 9, 2018
    Sponsor
    Yanhong Deng
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03629132
    Brief Title
    PRP Prevents Recurrence of Intrauterine Adhesions
    Acronym
    RPR-IUAs
    Official Title
    Platelet-rich Plasma(PRP) Prevents Recurrence of Intrauterine Adhesions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 15, 2018 (Anticipated)
    Primary Completion Date
    August 1, 2019 (Anticipated)
    Study Completion Date
    December 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Yanhong Deng

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Effect of platelet-rich plasma (PRP) on uterine scar fibrosis, endometrial receptivity and pregnancy outcome in patients with severe intrauterine adhesions
    Detailed Description
    Inclusion criteria: patients with intrauterine adhesions (AFS score >9 points); age 21 to 40 years old, with fertility requirements. Study design:prospective, randomized controlled cohort study, patients with intrauterine adhesions were randomized into two groups, the control group and the intervention group (intraoperative and postoperative 1 week postoperative PRP). The surgical procedures and postoperative medication regimens were the same. Compare the biochemical pregnancy rate, clinical pregnancy rate, abortion rate and live birth rate after hysteroscopic resection in PRP group and control group, and explore the effect of PRP on pregnancy outcome after intrauterine adhesion.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intrauterine Adhesion

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PRP
    Arm Type
    Experimental
    Arm Description
    Platelet-rich plasma
    Arm Title
    Gel
    Arm Type
    Sham Comparator
    Arm Description
    Self-crosslinking sodium hyaluronate gel
    Intervention Type
    Procedure
    Intervention Name(s)
    Platelet-rich plasma
    Intervention Description
    Platelet-rich plasma intrauterine injection
    Intervention Type
    Procedure
    Intervention Name(s)
    gel
    Intervention Description
    Self-crosslinking sodium hyaluronate gel intrauterine injection
    Primary Outcome Measure Information:
    Title
    AFS score
    Description
    AFS score
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    37 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria:Patients with intrauterine adhesions (AFS score >9 points); age 21 to 40 years old, with fertility requirements - Exclusion Criteria:Endometrial tuberculosis, endometrial polyps, uterine submucosal fibroids, endometrial hyperplasia, endometrial malignant lesions, premature ovarian failure, chromosomal abnormalities -

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    PRP Prevents Recurrence of Intrauterine Adhesions

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