Back to resultsKetoprofen With or Without Vaginal Isonicotinic Acid Hydrazide Prior to Hysterosalpingography
Primary Purpose
Infertility, Female
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ketoprofen + INH
Ketoprofen + placebo
Sponsored by
About this trial
This is an interventional prevention trial for Infertility, Female
Eligibility Criteria
Inclusion Criteria:
- any patient came for Hysterosalpingography
Exclusion Criteria:
- any patient has contraindication to HSG
Sites / Locations
- Aswan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group A
Group B
Arm Description
patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table 900 mg vaginal isonicotinic acid hydrazide by the patient 12 hours before the procedure
patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table vaginal placebo by the patient 12 hours before the procedure
Outcomes
Primary Outcome Measures
Intensity of pain
pain during the procedure assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable
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
Full Information
NCT ID
NCT04500470
First Posted
August 3, 2020
Last Updated
January 17, 2022
Sponsor
Aswan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04500470
Brief Title
Ketoprofen With or Without Vaginal Isonicotinic Acid Hydrazide Prior to Hysterosalpingography
Official Title
Ketoprofen With or Without Vaginal Isonicotinic Acid Hydrazide (INH) Prior to Hysterosalpingography in Primarily Infertile Patients: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
September 1, 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
The aim of our study is to determine the efficacy of Ketoprofen with or without vaginal isonicotinic acid hydrazide on the pain scores during HSG.
Detailed Description
hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye
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
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double blind placebo randomized controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double blind placebo randomized controlled trial
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table 900 mg vaginal isonicotinic acid hydrazide by the patient 12 hours before the procedure
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table vaginal placebo by the patient 12 hours before the procedure
Intervention Type
Drug
Intervention Name(s)
Ketoprofen + INH
Intervention Description
patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table 900 mg vaginal isonicotinic acid hydrazide by the patient 12 hours before the procedure
Intervention Type
Drug
Intervention Name(s)
Ketoprofen + placebo
Intervention Description
patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table placebo by the patient 12 hours before the procedure
Primary Outcome Measure Information:
Title
Intensity of pain
Description
pain during the procedure assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable
Time Frame
15 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
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female candidate for 30 minutes after the procedure
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
any patient came for Hysterosalpingography
Exclusion Criteria:
any patient has contraindication to HSG
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
Ketoprofen With or Without Vaginal Isonicotinic Acid Hydrazide Prior to Hysterosalpingography
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