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

Primary Purpose

Infertility, Female

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
INH
Placebo
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infertility, Female

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Aswan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

INH

Placebo Comparator

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Operative time
From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination

Full Information

First Posted
August 3, 2020
Last Updated
September 27, 2021
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04500522
Brief Title
Vaginal Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients
Official Title
Vaginal Isonicotinic Acid Hydrazide (INH) Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
double blind randomized controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double blind randomized controlled trial
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
INH
Arm Type
Experimental
Arm Description
3 vaginal tablet of isonicotinic acid hydrazide (INH) 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy.
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
3 vaginal tablet of Placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.
Intervention Type
Drug
Intervention Name(s)
INH
Other Intervention Name(s)
isonicotinic acid hydrazide
Intervention Description
3 vaginal tablet of isonicotinic acid hydrazide 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3 vaginal tablet of Placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.
Primary Outcome Measure Information:
Title
The difference in pain scores
Description
Pain intensity will be assessed by visual analogue scale during the procedure. visual analogue scale ranging from 0 to 10
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Intensity of pain
Description
Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10
Time Frame
30 minutes after the procedure
Title
Operative time
Description
From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination
Time Frame
15 minutes

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
nulliparous women with primary infertility
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
nahla w Shady, md
Organizational Affiliation
Aswan universirty
Official's Role
Study Chair
Facility Information:
Facility Name
Aswan University Hospital
City
Aswan
ZIP/Postal Code
81528
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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