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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility, Female

Intervention / Treatment
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* Drug: INH
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blind randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INH<br>3 vaginal tablet of isonicotinic acid hydrazide (INH) 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy. | Drug: INH<br>* 3 vaginal tablet of isonicotinic acid hydrazide 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy.<br>* Other names: isonicotinic acid hydrazide;|
| Placebo Comparator: Placebo Comparator<br>3 vaginal tablet of Placebo inserted by the patient 12 hours before the scheduled office hysteroscopy. | Drug: Placebo<br>* 3 vaginal tablet of Placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Operative time | From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination | 15 minutes |