Diclofenac Potassium With or Without Vaginal Dinoprostone Prior to Hysterosalpingography

NCT ID: NCT04500509

Last Updated: 2022-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-10-30

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.

Conditions

Infertility, Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

diclofenac potassium + dinoprostone

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

diclofenac potassium + placebo

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• primary infertility female came for HSG

Exclusion Criteria

• any patient has contraindication to HSG

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

hany farouk

A Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

nahla w Shady, md

Role: STUDY_CHAIR

Aswan universirty

Locations

Aswan University Hospital

Aswān, , Egypt

Countries

Egypt

Other Identifiers

aswu/352/3/19

Identifier Type: -

Identifier Source: org_study_id