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

Infertility, Female Clinical Trial

Official title:

Vaginal Isonicotinic Acid Hydrazide (INH) Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04500522
• Other study ID #: aswu/355/4/19
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

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