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Vaginal Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients

Sponsor
Aswan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04500522
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
12.5
Actual Duration (Months)
12
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the effectiveness of vaginal isonicotinic acid hydrazide 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
double blind randomized controlled trialdouble blind randomized controlled trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
double blind randomized controlled trial
Primary Purpose:
Prevention
Official Title:
Vaginal Isonicotinic Acid Hydrazide (INH) Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients: a Randomized Controlled Trial
Actual Study Start Date :
Sep 1, 2020
Actual Primary Completion Date :
Aug 30, 2021
Actual Study Completion Date :
Sep 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: INH

3 vaginal tablet of isonicotinic acid hydrazide (INH) 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy.

Drug: INH
3 vaginal tablet of isonicotinic acid hydrazide 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy.
Other Names:
  • isonicotinic acid hydrazide

    		•
    Placebo Comparator: Placebo Comparator

    3 vaginal tablet of Placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.

    Drug: Placebo
    3 vaginal tablet of Placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.

    Outcome Measures

    Primary Outcome Measures

    1. The difference in pain scores [10 minutes]

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

    Secondary Outcome Measures

    1. Intensity of pain [30 minutes after the procedure]

      Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10

    2. Operative time [15 minutes]

      From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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 isonicotinic acid hydrazide

    • those who received analgesics prior to office heavy vaginal bleeding

    • recent pelvic infection

    • a concomitant neurologic disease that could affect the correct evaluation of pain

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aswan University Hospital Aswan Egypt 81528

    Sponsors and Collaborators

    • Aswan University Hospital

    Investigators

    • Study Chair: nahla w Shady, md, Aswan universirty

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    hany farouk, A Professor, Aswan University Hospital
    ClinicalTrials.gov Identifier:
    NCT04500522
    Other Study ID Numbers:
    • aswu/355/4/19
    First Posted:
    Aug 5, 2020
    Last Update Posted:
    Sep 29, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infertility
    Infertility, Female
    Isoniazid

    Study Results

    No Results Posted as of Sep 29, 2021