- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04500509
Diclofenac Potassium With or Without Vaginal Dinoprostone Prior to Hysterosalpingography
January 17, 2022 updated by: hany farouk, Aswan University Hospital
Diclofenac Potassium With or Without Vaginal Dinoprostone Prior to Hysterosalpingography in Primarily Infertile Patients: a Randomized Controlled Trial
The aim of our study is to determine the efficacy of oral diclofenac potassium with or without vaginal dinoprostone prior to hysterosalpingography in primarily infertile patients on the pain scores during HSG.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
hysterosalpingography is a diagnosis procedure in the evaluation of infertile women and considered to be the traditional and the gold standard in the assessment of the patency of the fallopian tubes.
The major disadvantage of hysterosalpingography is pain.
In a study reported the patients complained of moderate to severe pain during the procedure.
It is reported that some patients undergoing hysterosalpingography was more stressful and anxiety and effect on pain scores.
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
-
-
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Aswan, Egypt, 81528
- Aswan University Hospital
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-
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 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- primary infertility female came for HSG
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 diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal dinoprostone (6 mg) 6 hours prior to the procedure
|
patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal dinoprostone (6 mg) 6 hours prior to the procedure by the patient
|
Placebo Comparator: Group B
patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal placebo 6 hours prior to the procedure
|
patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal placebo 6 hours prior to the procedure by the patient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean pain score during hysterosalpigography by visual analog scale
Time Frame: 15 minutes
|
pain during hysterosalpigography 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)
August 1, 2021
Study Completion (Actual)
October 30, 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
- Reproductive Control Agents
- Oxytocics
- Diclofenac
- Dinoprostone
Other Study ID Numbers
- aswu/352/3/19
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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