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

NCT04500522 | Completed Phase 4 DMC

• 1 other identifier: aswu/355/4/19
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Intensity of pain

  30 minutes after the procedure

• Operative time

  15 minutes

Study Arms (2)

INH

EXPERIMENTAL

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

Drug: INH

Placebo Comparator

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

INH DRUG

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

Also known as: isonicotinic acid hydrazide

INH

Placebo DRUG

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

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: nulliparous women with primary infertility
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• nulliparous women with primary infertility requiring a diagnostic hysteroscopy as a part of an infertility diagnosis workup

You may not qualify if:

• 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

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Isoniazid

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• nahla w Shady, md

  Aswan universirty

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind randomized controlled trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A Professor

Model Details: double blind randomized controlled trial

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 5, 2020
• Study Start: September 1, 2020
• Primary Completion: August 30, 2021
• Study Completion: September 15, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)