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

Aswan University Hospital150 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

150

Conditions

Infertility, Female

Interventions

INHDRUG

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

PlaceboDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Aswan University Hospital

Aswān, Egypt

Outcomes

Primary Outcomes

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

Time frame: 10 minutes

Secondary Outcomes

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

Time frame: 30 minutes after the procedure

Operative time

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

Time frame: 15 minutes

Data from ClinicalTrials.gov

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