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

Phase 4

Completed

• Conditions: Infertility, Female
• Interventions: Drug: Placebo; Drug: INH

• Registration Number: NCT04500522
• Lead Sponsor: Aswan University Hospital

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.

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 Timeline

• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-05
• Study Start: 2020-09-01
• Primary Completion: 2021-08-30
• Status Verified: 2021-09
• Study Completion: 2021-09-15
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Operative time	15 minutes	From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination
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

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt