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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04500509
Other study ID # aswu/352/3/19
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date October 30, 2021

Study information

Verified date January 2022
Source Aswan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date October 30, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - primary infertility female came for HSG Exclusion Criteria: - any patient has contraindication to HSG

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
diclofenac potassium + dinoprostone
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
diclofenac potassium + placebo
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

Locations

Country Name City State
Egypt Aswan University Hospital Aswan

Sponsors (1)

Lead Sponsor Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 15 minutes
Secondary 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 30 minutes after the procedure
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