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Assisted Hatching Versus Endometrial Scratch in Recurrent Implantation Failure

Primary Purpose

Recurrent Implantation Failure

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
endometrial scratch
assisted hatching
controlled ovarian hyperstimulation
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Implantation Failure

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • recurrent implantation failure
  • normal uterine cavity by transvaginal ultrasound

Exclusion Criteria:

  • endometrial polyp or fibroid distorting the endometrium
  • hydrosalpinx
  • preimplantation genetic diagnosis
  • severe male factor

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Sham Comparator

    Arm Label

    Endometrial scratch group

    Assisted hatching group

    ovarian stimulation only group

    Arm Description

    endometrial scratch controlled ovarian hyperstimulation

    assisted hatching controlled ovarian hyperstimulation

    controlled ovarian hyperstimulation

    Outcomes

    Primary Outcome Measures

    number of patients with positive pregnancy test

    Secondary Outcome Measures

    Full Information

    First Posted
    April 25, 2016
    Last Updated
    April 26, 2016
    Sponsor
    Kasr El Aini Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02752568
    Brief Title
    Assisted Hatching Versus Endometrial Scratch in Recurrent Implantation Failure
    Official Title
    Assisted Hatching Versus Endometrial Scratch in Recurrent Implantation Failure.A Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    November 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kasr El Aini Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    300 recurrent implantation failure patients will be alternatively assigned to assisted hatching , endometrial scratch , and no treatment ,100 patients in each group
    Detailed Description
    Group 1 consists of 100 patients will undergo endometrial scratch followed by controlled ovarian hyperstimulation Group 2 consists of 100 patients will undergo controlled ovarian hyperstimulation& assisted hatching Group 3 consists of 100 patients will undergo controlled ovarian hyperstimulation

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Implantation Failure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Endometrial scratch group
    Arm Type
    Active Comparator
    Arm Description
    endometrial scratch controlled ovarian hyperstimulation
    Arm Title
    Assisted hatching group
    Arm Type
    Active Comparator
    Arm Description
    assisted hatching controlled ovarian hyperstimulation
    Arm Title
    ovarian stimulation only group
    Arm Type
    Sham Comparator
    Arm Description
    controlled ovarian hyperstimulation
    Intervention Type
    Procedure
    Intervention Name(s)
    endometrial scratch
    Other Intervention Name(s)
    endometrial injury
    Intervention Description
    midluteal endometrial scratch using Novak curette under general anesthesia in the cycle preceding stimulation
    Intervention Type
    Procedure
    Intervention Name(s)
    assisted hatching
    Other Intervention Name(s)
    laser hatching
    Intervention Description
    using Octax laser 20120644-laser 5452
    Intervention Type
    Procedure
    Intervention Name(s)
    controlled ovarian hyperstimulation
    Intervention Description
    using merional&/ or fostimon doses individualized as judged by patient age & ovarian reserve & monitored by follicular size & serum estradiol
    Primary Outcome Measure Information:
    Title
    number of patients with positive pregnancy test
    Time Frame
    2 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: recurrent implantation failure normal uterine cavity by transvaginal ultrasound Exclusion Criteria: endometrial polyp or fibroid distorting the endometrium hydrosalpinx preimplantation genetic diagnosis severe male factor
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    suzy abdelaziz, lecturer
    Phone
    01003726195
    Email
    suzyabdelaziz92@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    suzy abdelaziz, lecturer
    Organizational Affiliation
    kasrelaini hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33730422
    Citation
    Lacey L, Hassan S, Franik S, Seif MW, Akhtar MA. Assisted hatching on assisted conception (in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI)). Cochrane Database Syst Rev. 2021 Mar 17;3(3):CD001894. doi: 10.1002/14651858.CD001894.pub6.
    Results Reference
    derived

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    Assisted Hatching Versus Endometrial Scratch in Recurrent Implantation Failure

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