Diclofenac Potassium With or Without Vaginal Dinoprostone Prior to Hysterosalpingography

Not Applicable

Completed

• Conditions: Infertility, Female
• Interventions: Drug: diclofenac potassium + dinoprostone; Drug: diclofenac potassium + placebo

• Registration Number: NCT04500509
• Lead Sponsor: Aswan University Hospital

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.

Study Timeline

• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-05
• Study Start: 2020-09-01
• Primary Completion: 2021-08-01
• Study Completion: 2021-10-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-17
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• primary infertility female came for HSG

Exclusion Criteria

• any patient has contraindication to HSG

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	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
Group B	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

Primary Outcome Measures

Name	Time	Method
Mean pain score during hysterosalpigography by visual analog scale	15 minutes	pain during hysterosalpigography assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable

Secondary Outcome Measures

Name	Time	Method
Intensity of pain	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

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt