Diclofenac Potassium With or Without Vaginal Dinoprostone Prior to Hysterosalpingography

Infertility, Female Clinical Trial

Official title:

Diclofenac Potassium With or Without Vaginal Dinoprostone Prior to Hysterosalpingography in Primarily Infertile Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04500509
• Other study ID #: aswu/352/3/19
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

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