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

NCT ID: NCT04500522

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-09-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

INH

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

Group Type: EXPERIMENTAL

INH

Intervention Type: DRUG

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

Placebo Comparator

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

INH

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

isonicotinic acid hydrazide

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

hany farouk

A Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

nahla w Shady, md

Role: STUDY_CHAIR

Aswan universirty

Locations

Aswan University Hospital

Aswān, , Egypt

Countries

Egypt

Other Identifiers

aswu/355/4/19

Identifier Type: -

Identifier Source: org_study_id