Ketoprofen With or Without Vaginal Isonicotinic Acid Hydrazide Prior to Hysterosalpingography

Infertility, Female Clinical Trial

Official title:

Ketoprofen With or Without Vaginal Isonicotinic Acid Hydrazide (INH) Prior to Hysterosalpingography in Primarily Infertile Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04500470
• Other study ID #: aswu/351/3/19
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 1, 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 Ketoprofen with or without vaginal isonicotinic acid hydrazide on the pain scores during HSG.

Description:

hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 1, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• any patient came for Hysterosalpingography

Exclusion Criteria:

• any patient has contraindication to HSG

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Drug:
• Ketoprofen + INH
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
• Ketoprofen + placebo
patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table placebo by the patient 12 hours before the procedure

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	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	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