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Analgesia for Endometrial Scratching

Primary Purpose

Subfertility, Infertility

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ibuprofen 600 mg
Lorazepam 1 mg
Placebo
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Subfertility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women aged ≥ 18 years undergoing assisted reproduction (IUI, IVF/ICSI, frozen embryo transfer)
  • Being submitted to endometrial scratching/injury with a Pipelle on the first four days of the menstrual cycle.
  • Not have performed endometrial scratching in the last 90 days.

Exclusion Criteria:

- None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Ibuprofen+Lorazepam

    Ibuprofen

    Placebo

    Arm Description

    Oral ibuprofen (600 mg) + lorazepam (1 mg); one hour before endometrial scratching.

    Oral ibuprofen (600 mg) + Placebo; one hour before endometrial scratching.

    Placebo + Placebo; one hour before endometrial scratching.

    Outcomes

    Primary Outcome Measures

    Maximum pain during procedure
    Evaluated by both visual analog scale (10 cm) and numeric verbal scale (0 to 10).

    Secondary Outcome Measures

    Pain after the procedure
    Evaluated by both visual analog scale (10 cm) and numeric verbal scale (0 to 10).
    Rejection to a new procedure
    Evaluated by a 5-point Likert scale, commenting on this sentence: "I would repeat this procedure if it were indicated". 1 = I fully agree; 2 = I agree; 3 =Neither agree nor disagree; 4 = Disagree; 5 = Strongly Disagree.

    Full Information

    First Posted
    August 8, 2016
    Last Updated
    May 7, 2018
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02863614
    Brief Title
    Analgesia for Endometrial Scratching
    Official Title
    Analgesia for Endometrial Scratching in Subfertile Women: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (Actual)
    Primary Completion Date
    May 2017 (Actual)
    Study Completion Date
    May 2017 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to evaluate whether Ibuprofen alone or combined with lorazepam reduce the pain associated with endometrial scratching/injury.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ibuprofen+Lorazepam
    Arm Type
    Experimental
    Arm Description
    Oral ibuprofen (600 mg) + lorazepam (1 mg); one hour before endometrial scratching.
    Arm Title
    Ibuprofen
    Arm Type
    Active Comparator
    Arm Description
    Oral ibuprofen (600 mg) + Placebo; one hour before endometrial scratching.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo + Placebo; one hour before endometrial scratching.
    Intervention Type
    Drug
    Intervention Name(s)
    Ibuprofen 600 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Lorazepam 1 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Maximum pain during procedure
    Description
    Evaluated by both visual analog scale (10 cm) and numeric verbal scale (0 to 10).
    Time Frame
    5 minutes
    Secondary Outcome Measure Information:
    Title
    Pain after the procedure
    Description
    Evaluated by both visual analog scale (10 cm) and numeric verbal scale (0 to 10).
    Time Frame
    5 minutes
    Title
    Rejection to a new procedure
    Description
    Evaluated by a 5-point Likert scale, commenting on this sentence: "I would repeat this procedure if it were indicated". 1 = I fully agree; 2 = I agree; 3 =Neither agree nor disagree; 4 = Disagree; 5 = Strongly Disagree.
    Time Frame
    5 minutes

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women aged ≥ 18 years undergoing assisted reproduction (IUI, IVF/ICSI, frozen embryo transfer) Being submitted to endometrial scratching/injury with a Pipelle on the first four days of the menstrual cycle. Not have performed endometrial scratching in the last 90 days. Exclusion Criteria: - None

    12. IPD Sharing Statement

    Learn more about this trial

    Analgesia for Endometrial Scratching

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