Diclofenac Potassium With or Without Vaginal Dinoprostone Prior to Hysterosalpingography

NCT04500509 | Completed DMC

• 1 other identifier: aswu/352/3/19
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Intensity of pain

  30 minutes after the procedure

Study Arms (2)

Group A

EXPERIMENTAL

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

Drug: diclofenac potassium + dinoprostone

Group B

PLACEBO COMPARATOR

patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal placebo 6 hours prior to the procedure

Drug: diclofenac potassium + placebo

Interventions

diclofenac potassium + dinoprostone 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 A

diclofenac potassium + placebo 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

Group B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: primary infertility female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• primary infertility female came for HSG

You may not qualify if:

• any patient has contraindication to HSG

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Diclofenac; Dinoprostone

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• nahla w Shady, md

  Aswan universirty

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind placebo controlled trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A Professor

Model Details: double blind placebo controlled trial

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 5, 2020
• Study Start: September 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: October 30, 2021
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)