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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INH | Experimental | 3 vaginal tablet of isonicotinic acid hydrazide (INH) 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy. |
|
| Placebo Comparator | Placebo Comparator | 3 vaginal tablet of Placebo inserted by the patient 12 hours before the scheduled office hysteroscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INH | Drug | 3 vaginal tablet of isonicotinic acid hydrazide 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
nulliparous women with primary infertility
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| Name | Affiliation | Role |
|---|---|---|
| nahla w Shady, md | Aswan universirty | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aswan University Hospital | Aswān | 81528 | Egypt |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D007538 | Isoniazid |
| ID | Term |
|---|---|
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D007539 | Isonicotinic Acids |
| D000147 | Acids, Heterocyclic |
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double blind randomized controlled trial
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double blind randomized controlled trial
| Placebo | Drug | 3 vaginal tablet of Placebo inserted by the patient 12 hours before the scheduled office hysteroscopy. |
|
From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination
| 15 minutes |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
| D006571 |
| Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |