Back to resultsDiclofenac Potassium With or Without Vaginal Dinoprostone Prior to Hysterosalpingography
Primary Purpose
Infertility, Female
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
diclofenac potassium + dinoprostone
diclofenac potassium + placebo
Sponsored by
About this trial
This is an interventional prevention trial for Infertility, Female
Eligibility Criteria
Inclusion Criteria:
- primary infertility female came for HSG
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 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 placebo 6 hours prior to the procedure
Outcomes
Primary Outcome Measures
Mean pain score during hysterosalpigography by visual analog scale
pain during hysterosalpigography 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
NCT04500509
First Posted
August 3, 2020
Last Updated
January 17, 2022
Sponsor
Aswan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04500509
Brief Title
Diclofenac Potassium With or Without Vaginal Dinoprostone Prior to Hysterosalpingography
Official Title
Diclofenac Potassium With or Without Vaginal Dinoprostone 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
August 1, 2021 (Actual)
Study Completion Date
October 30, 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 oral diclofenac potassium with or without vaginal dinoprostone prior to hysterosalpingography in primarily infertile patients on the pain scores during HSG.
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.
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 controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double blind placebo 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 diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal dinoprostone (6 mg) 6 hours prior to the procedure
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal placebo 6 hours prior to the procedure
Intervention Type
Drug
Intervention Name(s)
diclofenac potassium + dinoprostone
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
diclofenac potassium + placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean pain score during hysterosalpigography by visual analog scale
Description
pain during hysterosalpigography 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
primary infertility female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
primary infertility female came for HSG
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
Diclofenac Potassium With or Without Vaginal Dinoprostone Prior to Hysterosalpingography
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