search
Back to results

Does Endometrial Injury Improve Intrauterine Insemination Outcome?

Primary Purpose

Infertility

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
endometrial injury.
intrauterine insemination
ovarian stimulation
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 - 38 years.
  • patent fallopian tunes.
  • mild male factor.
  • anovulation.
  • unexplained infertility.

Exclusion Criteria:

  • indications for ICSI.
  • evidence of pelvic inflammatory disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    endometrial injury

    no endometrial injury

    Arm Description

    Endometrial injury during ovarian stimulation combined with intrauterine insemination.

    Ovarian stimulation combined with intrauterine insemination.

    Outcomes

    Primary Outcome Measures

    Chemical Pregnancy Rate
    Human chorionic gonadotrophin (b-hcg) detection in serum two weeks after intrauterine insemination.
    Clinical Pregnancy Rate
    Ultrasound detection of an intrauterine positive fetal heart pulsations

    Secondary Outcome Measures

    Full Information

    First Posted
    September 3, 2015
    Last Updated
    December 3, 2015
    Sponsor
    Ain Shams Maternity Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02542280
    Brief Title
    Does Endometrial Injury Improve Intrauterine Insemination Outcome?
    Official Title
    Endometrial Injury May Increase the Pregnancy Rate in Patients Undergoing Intrauterine Insemination
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2013 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams Maternity Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The investigator suggests that local endometrial injury using pipelle catheter performed in the follicular phase (cycle day 5, 6 or 7) of the stimulation cycle may improve the pregnancy rates among patients undergoing intrauterine insemination.
    Detailed Description
    In a selected group of patients with repeated implantation failure, endometrial injury in the preceding cycle may improve ICSI outcome. Little is known about the efficacy of this procedure in improving intrauterine insemination outcome. Also little is known about the effect of this procedure if done in the stimulation cycle weather in ICSI or intrauterine insemination cycles.

    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
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    360 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    endometrial injury
    Arm Type
    Experimental
    Arm Description
    Endometrial injury during ovarian stimulation combined with intrauterine insemination.
    Arm Title
    no endometrial injury
    Arm Type
    Active Comparator
    Arm Description
    Ovarian stimulation combined with intrauterine insemination.
    Intervention Type
    Procedure
    Intervention Name(s)
    endometrial injury.
    Other Intervention Name(s)
    endometrial scratch., endometrial sample.
    Intervention Description
    Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.
    Intervention Type
    Procedure
    Intervention Name(s)
    intrauterine insemination
    Other Intervention Name(s)
    artificial insemination
    Intervention Description
    Placement of washed sperm in the uterus using a catheter, around the time of ovulation.
    Intervention Type
    Drug
    Intervention Name(s)
    ovarian stimulation
    Other Intervention Name(s)
    controlled ovarian hyperstimulatiom
    Intervention Description
    Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm.
    Primary Outcome Measure Information:
    Title
    Chemical Pregnancy Rate
    Description
    Human chorionic gonadotrophin (b-hcg) detection in serum two weeks after intrauterine insemination.
    Time Frame
    two weeks after intrauterine insemination
    Title
    Clinical Pregnancy Rate
    Description
    Ultrasound detection of an intrauterine positive fetal heart pulsations
    Time Frame
    six weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    38 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 - 38 years. patent fallopian tunes. mild male factor. anovulation. unexplained infertility. Exclusion Criteria: indications for ICSI. evidence of pelvic inflammatory disease.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed Bahaa
    Organizational Affiliation
    Lecturer in Obstetrics and Gynecology, faculty of medicine, Ain Shams University.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Does Endometrial Injury Improve Intrauterine Insemination Outcome?

    We'll reach out to this number within 24 hrs