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Endometrial Scratch Injury in Women With Unexplained Infertility Undergoing IUI

Primary Purpose

Unexplained Infertility

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
endometrial scratch injury
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unexplained Infertility focused on measuring Endometrial Scratch Injury, Unexplained infertility, intrauterine insemenation, ovulation induction

Eligibility Criteria

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

Inclusion Criteria:

1. Couple with unexplained infertility and assigned for IUI

Exclusion Criteria:

  1. Woman's age of more than 40 years
  2. Ovarian cyst detected in the ultrasound examination
  3. Uterine lesions such as submucosal leiomyoma
  4. A previous diagnosis of moderate to severe pelvic endometriosis
  5. Women with body mass index ≥35 kg/m2 o
  6. Women with signs of hyperandrogenemia dy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    endometrial scratch injury

    Non endometrial scratch injury

    Arm Description

    Patients received 100 mg of oral clomiphene citrate for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG was injected intramuscularly. Group S had ESI using No.8 neonatal feeding tube and after 24 to 36 hours, IUI was performed.

    Patients received 100 mg of oral clomiphene citrate for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG was injected intramuscularly. Group C received IUI without ESI and after 24 to 36 hours, IUI was performed.

    Outcomes

    Primary Outcome Measures

    clinical pregnancy

    Secondary Outcome Measures

    Full Information

    First Posted
    January 24, 2015
    Last Updated
    January 28, 2015
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02349750
    Brief Title
    Endometrial Scratch Injury in Women With Unexplained Infertility Undergoing IUI
    Official Title
    Endometrial Scratch Injury Induced Higher Pregnancy Rate for Women With Unexplained Infertility Undergoing IUI With Ovarian Stimulation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    January 2013 (Actual)
    Study Completion Date
    January 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study included 154 infertile women Patients received 100 mg of oral clomiphene citrate for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG was injected intramuscularly. Patients were randomly allocated into two equal groups: Group C received IUI without ESI and Group S had ESI using No.8 neonatal feeding tube and after 24 to 36 hours, IUI was performed. Successful pregnancy was con-firmed by ultrasound and patients had failed trial underwent another trial of IUI for a maximum of three trials.
    Detailed Description
    The study included 154 infertile women with mean duration of infertility of 3.9±0.4 years. Patients received 100 mg of oral clomiphene citrate for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG was injected intramuscularly. Patients were randomly allocated into two equal groups: Group C received IUI without ESI and Group S had ESI using No.8 neonatal feeding tube and after 24 to 36 hours, IUI was performed. Successful pregnancy was con-firmed by ultrasound and patients had failed trial underwent another trial of IUI for a maximum of three trials.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Unexplained Infertility
    Keywords
    Endometrial Scratch Injury, Unexplained infertility, intrauterine insemenation, ovulation induction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    154 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    endometrial scratch injury
    Arm Type
    Active Comparator
    Arm Description
    Patients received 100 mg of oral clomiphene citrate for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG was injected intramuscularly. Group S had ESI using No.8 neonatal feeding tube and after 24 to 36 hours, IUI was performed.
    Arm Title
    Non endometrial scratch injury
    Arm Type
    No Intervention
    Arm Description
    Patients received 100 mg of oral clomiphene citrate for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG was injected intramuscularly. Group C received IUI without ESI and after 24 to 36 hours, IUI was performed.
    Intervention Type
    Procedure
    Intervention Name(s)
    endometrial scratch injury
    Intervention Description
    ESI using No.8 neonatal feeding tube
    Primary Outcome Measure Information:
    Title
    clinical pregnancy
    Time Frame
    14 days after IUI

    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: 1. Couple with unexplained infertility and assigned for IUI Exclusion Criteria: Woman's age of more than 40 years Ovarian cyst detected in the ultrasound examination Uterine lesions such as submucosal leiomyoma A previous diagnosis of moderate to severe pelvic endometriosis Women with body mass index ≥35 kg/m2 o Women with signs of hyperandrogenemia dy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed M Maged, MD
    Organizational Affiliation
    Kasr Alainy medical school
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Endometrial Scratch Injury in Women With Unexplained Infertility Undergoing IUI

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