search
Back to results

Endometrial Injury in Women With Unexplained Infertility

Primary Purpose

Unexplained Infertility

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endometrial injury
Sponsored by
Mansoura Integrated Fertility Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unexplained Infertility

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age between 18 and 39 years old.
  2. Normal HSG and/or diagnostic laparoscopy.
  3. Normal seminal profile.
  4. Regular ovulation confirmed by mid-luteal progesterone.
  5. Normal TVS criteria.

Exclusion Criteria:

  1. Uterine fibroid.
  2. Pelvic endometriosis.
  3. Irregular menstruation.
  4. Ovarian cysts.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Endometrial injury

    Arm Description

    Hysteroscopic-guided endometrial injury (Karl Storz, Tuttlingen, Germany).

    Outcomes

    Primary Outcome Measures

    Clinical pregnancy rates (PR)

    Secondary Outcome Measures

    Miscarriage rates

    Full Information

    First Posted
    December 8, 2015
    Last Updated
    December 10, 2015
    Sponsor
    Mansoura Integrated Fertility Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02628756
    Brief Title
    Endometrial Injury in Women With Unexplained Infertility
    Official Title
    Endometrial Injury Does Not Improve Pregnancy Rates in Women With Unexplained Infertility
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mansoura Integrated Fertility Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Women between 18-39 years old who had been infertile (primary or secondary) for at least 1 year were recruited. In a parallel assignment eligible participants were randomized to receive either a single, site-specific endometrial injury guided by hysteroscopy (Study group) or no intervention (Control group). Natural cycle folliculometry + timed sexual intercourse were offered for all participants for the ongoing and the immediate 2 concecutive cycles. Clinical pregnancy rates were the primary outcome and miscarriage rates were the secondary outcome measures.
    Detailed Description
    A single site-specific hysteroscopic injury procedure (Snip) will be performed using an office hysteroscopy (Karl Storz, Germany). By means of vaginoscopy, a 2.9 mm. continuous-flow diagnostic hysteroscope with a 5 Fr. working-channel is guided through the cervical canal with normal saline as distension medium, with flow manually regulated through the key of the hysteroscopic sheath. The examination of the uterine cavity begins by observing its regularity, paying special attention to the presence of intrauterine malformations or morphologic alterations such as submucous myomas, or uterine septa. Subsequently, A claw forceps will be introduced through a 2.2 mm working channel, and will be used to generate a local injury on the upper posterior endometrium (Endometrial Snip) at midline 10-15 mm from the fundus on D4 to D7 of the ongoing menstrual cycle. The depth and width of the injured site will be about 2x2 mm (i.e a single bite of the claw forceps). No premedications, antibiotics or hemostatics will be given after the procedure. Natural cycle folliculometry + timed sexual intercourse will be offered for all participants for the ongoing and the immediate subsequent cycles. Once the leading ovarian follicle will reach a size of at least 16 mm, 10,000 IU of hCG will be administered to trigger ovulation.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Endometrial injury
    Arm Type
    Experimental
    Arm Description
    Hysteroscopic-guided endometrial injury (Karl Storz, Tuttlingen, Germany).
    Intervention Type
    Procedure
    Intervention Name(s)
    Endometrial injury
    Intervention Description
    Office hysteroscopy (Karl Storz, Tuttlingen, Germany)
    Primary Outcome Measure Information:
    Title
    Clinical pregnancy rates (PR)
    Time Frame
    Three consecutive months
    Secondary Outcome Measure Information:
    Title
    Miscarriage rates
    Time Frame
    Three consecutive months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age between 18 and 39 years old. Normal HSG and/or diagnostic laparoscopy. Normal seminal profile. Regular ovulation confirmed by mid-luteal progesterone. Normal TVS criteria. Exclusion Criteria: Uterine fibroid. Pelvic endometriosis. Irregular menstruation. Ovarian cysts.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tarek Shokeir, M.D.
    Organizational Affiliation
    Mansoura University Hospital, Mansoura Faculty of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Endometrial Injury in Women With Unexplained Infertility

    We'll reach out to this number within 24 hrs