Ketoprofen With or Without Vaginal Isonicotinic Acid Hydrazide Prior to Hysterosalpingography

NCT04500470 | Completed DMC

• 1 other identifier: aswu/351/3/19
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to determine the efficacy of Ketoprofen with or without vaginal isonicotinic acid hydrazide on the pain scores during HSG.

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

• Intensity of pain

  pain during the procedure 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 Ketoprofen 60 minutes before the procedure plus 3 table 900 mg vaginal isonicotinic acid hydrazide by the patient 12 hours before the procedure

Drug: Ketoprofen + INH

Group B

PLACEBO COMPARATOR

patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table vaginal placebo by the patient 12 hours before the procedure

Drug: Ketoprofen + placebo

Interventions

Ketoprofen + INH DRUG

patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table 900 mg vaginal isonicotinic acid hydrazide by the patient 12 hours before the procedure

Group A

Ketoprofen + placebo DRUG

patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table placebo by the patient 12 hours before the procedure

Group B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: female candidate for 30 minutes after the procedure
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• any patient came for Hysterosalpingography

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

Ketoprofen; Isoniazid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydrazines; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

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 randomized controlled trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A Professor

Model Details: double blind placebo randomized controlled trial

Study Record Dates

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

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)