NCT04500522

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Aswan University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility, Female

Interventions

Type	Name	Description
DRUG	INH	3 vaginal tablet of isonicotinic acid hydrazide 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy.
DRUG	Placebo	3 vaginal tablet of Placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-08-30
• Completion: 2021-09-15
• First posted: 2020-08-05
• Last updated: 2021-09-29

Locations

1 site across 1 country: Egypt