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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04500522
Other study ID # aswu/355/4/19
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 1, 2020
Est. completion date September 15, 2021

Study information

Verified date September 2021
Source Aswan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date September 15, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Aswan University Hospital Aswan

Sponsors (1)

Lead Sponsor Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary The difference in pain scores Pain intensity will be assessed by visual analogue scale during the procedure. visual analogue scale ranging from 0 to 10 10 minutes
Secondary 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 30 minutes after the procedure
Secondary Operative time From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination 15 minutes
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