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Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients

Primary Purpose

Hysteroscopy

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
vaginal dinoprostone
placebo
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hysteroscopy

Eligibility Criteria

15 Years - 40 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • nulliparous women with primary infertility requiring a diagnostic hysteroscopy as a part of an infertility diagnosis workup

Exclusion Criteria:

  • • women with suspected pregnancy

    • heavy vaginal bleeding
    • recent pelvic infection
    • those known to have hypersensitivity or contraindication to dinoprostone
    • those who received analgesics prior to OH
    • a concomitant neurologic disease that could affect the correct evaluation of pain

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    dinoprostone

    placebo

    Arm Description

    1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.

    one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.

    Outcomes

    Primary Outcome Measures

    Intensity of pain
    Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10

    Secondary Outcome Measures

    Intensity of pain
    Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10
    Operative time
    From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination

    Full Information

    First Posted
    July 31, 2019
    Last Updated
    July 31, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04042974
    Brief Title
    Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients
    Official Title
    Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients:a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 10, 2019 (Anticipated)
    Primary Completion Date
    November 10, 2019 (Anticipated)
    Study Completion Date
    November 20, 2019 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To compare the effectiveness of vaginal dinoprostone with placebo in minimizing the pain experienced by primarily infertile patients during diagnostic office hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.
    Detailed Description
    hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, fibroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. Cervical ripening is made possible by the use of medication through different routes. The most commonly used agent is misoprostol, a synthetic prostaglandin E1 (PGE1) analog that is frequently administered in off-label use in obstetrics and gynecology for medical abortion, labor induction, endometrial biopsy, dilatation and curettage, intrauterine device insertion, myomectomy, postpartum haemorrhage, and cervical ripening. In contrast, dinoprostone, a natural PGE2, is mostly used in obstetrics for cervical ripening and the stimulation of uterine contractions to induce labor.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    dinoprostone
    Arm Type
    Experimental
    Arm Description
    1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.
    Intervention Type
    Drug
    Intervention Name(s)
    vaginal dinoprostone
    Intervention Description
    1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.
    Primary Outcome Measure Information:
    Title
    Intensity of pain
    Description
    Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10
    Time Frame
    an expected average of 10 minutes
    Secondary Outcome Measure Information:
    Title
    Intensity of pain
    Description
    Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10
    Time Frame
    30 minutes after the procedure
    Title
    Operative time
    Description
    From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination
    Time Frame
    an expected average 10 minutes

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: nulliparous women with primary infertility requiring a diagnostic hysteroscopy as a part of an infertility diagnosis workup Exclusion Criteria: • women with suspected pregnancy heavy vaginal bleeding recent pelvic infection those known to have hypersensitivity or contraindication to dinoprostone those who received analgesics prior to OH a concomitant neurologic disease that could affect the correct evaluation of pain
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    AHMED SAMY, MD
    Phone
    +201100681167
    Email
    ahmedsamy8233@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    AHMED SAMY, MD
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients

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