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

Aswan University Hospital

Status and phase: Completed; Phase 4

Conditions: Infertility, Female

Treatments: Drug: Placebo; Drug: INH

Study type: Interventional

Funder types: Other

Identifiers

NCT04500522

aswu/355/4/19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

INH

Experimental group

Description:

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

Treatment:

Drug: INH

Placebo Comparator

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo