- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04500470
Ketoprofen With or Without Vaginal Isonicotinic Acid Hydrazide Prior to Hysterosalpingography
January 17, 2022 updated by: hany farouk, Aswan University Hospital
Ketoprofen With or Without Vaginal Isonicotinic Acid Hydrazide (INH) Prior to Hysterosalpingography in Primarily Infertile Patients: a Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aswan, Egypt, 81528
- Aswan University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- any patient came for Hysterosalpingography
Exclusion Criteria:
- any patient has contraindication to HSG
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
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 900 mg vaginal isonicotinic acid hydrazide by the patient 12 hours before the procedure
|
Placebo Comparator: Group B
patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table vaginal placebo by the patient 12 hours before the procedure
|
patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table placebo by the patient 12 hours before the procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intensity of pain
Time Frame: 15 minutes
|
pain during the procedure assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intensity of pain
Time Frame: 30 minutes after the procedure
|
Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual
analogue scale ranging from 0 to 10
|
30 minutes after the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Actual)
July 30, 2021
Study Completion (Actual)
September 1, 2021
Study Registration Dates
First Submitted
August 3, 2020
First Submitted That Met QC Criteria
August 4, 2020
First Posted (Actual)
August 5, 2020
Study Record Updates
Last Update Posted (Actual)
January 19, 2022
Last Update Submitted That Met QC Criteria
January 17, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infertility
- Infertility, Female
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ketoprofen
Other Study ID Numbers
- aswu/351/3/19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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