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Expression of HOXA10 and HOXA11 in the Endometrium of Infertility Patients With an Endometrial Polyp Before and After Polypectomy

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endometrial biopsy
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

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

Inclusion Criteria:

  • Infertile women with endometrial polyp

Exclusion Criteria:

  • Endometriosis
  • Polycystic ovary syndrome
  • Hydrosalpinx
  • Sub-mucus myoma
  • Women who have taken hormonal therapy in the preceding month

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    HOXA10 and HOXA11 Expression Before Polypectomy

    HOXA10 and HOXA11 Expression After Polypectomy

    Arm Description

    A biopsy will taken in infertility patients with endometrial polyp before polypectomy

    A biopsy will taken in infertility patients with endometrial polyp 1-3 months after polypectomy

    Outcomes

    Primary Outcome Measures

    Comparison of amounts of HOXA10 and HOXA11 expressed before and after polypectomy

    Secondary Outcome Measures

    Full Information

    First Posted
    May 2, 2016
    Last Updated
    May 11, 2016
    Sponsor
    Hillel Yaffe Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02761278
    Brief Title
    Expression of HOXA10 and HOXA11 in the Endometrium of Infertility Patients With an Endometrial Polyp Before and After Polypectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    July 2017 (Anticipated)
    Study Completion Date
    July 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hillel Yaffe Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this study is to measure the expression of HOXA10 and HOXA11 in the endometrium of infertility patients with an endometrial polyp before and after polypectomy. HOXA10 and HOXA11 are well-established markers of implantation. It is uncertain as to whether an endometrial polyp interferes with embryo implantation. A higher expression of HOXA10 and HOXA11 after polypectomy can indicate that endometrial polyp does interfere with embryo implantation.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HOXA10 and HOXA11 Expression Before Polypectomy
    Arm Type
    Active Comparator
    Arm Description
    A biopsy will taken in infertility patients with endometrial polyp before polypectomy
    Arm Title
    HOXA10 and HOXA11 Expression After Polypectomy
    Arm Type
    Active Comparator
    Arm Description
    A biopsy will taken in infertility patients with endometrial polyp 1-3 months after polypectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    Endometrial biopsy
    Primary Outcome Measure Information:
    Title
    Comparison of amounts of HOXA10 and HOXA11 expressed before and after polypectomy
    Time Frame
    Four months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Infertile women with endometrial polyp Exclusion Criteria: Endometriosis Polycystic ovary syndrome Hydrosalpinx Sub-mucus myoma Women who have taken hormonal therapy in the preceding month
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Guy Shrem, MD
    Email
    dr.shremguy@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guy Shrem, MD
    Organizational Affiliation
    Hillel Yaffe Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Expression of HOXA10 and HOXA11 in the Endometrium of Infertility Patients With an Endometrial Polyp Before and After Polypectomy

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