Ketoprofen With or Without Vaginal Isonicotinic Acid Hydrazide Prior to Hysterosalpingography

Sponsor

Aswan University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04500470

Collaborator

(none)

200

Enrollment

Location

Arms

Actual Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female	Drug: Ketoprofen + INH Drug: Ketoprofen + placebo	N/A

Detailed 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

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

double blind placebo randomized controlled trialdouble blind placebo randomized controlled trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

double blind placebo randomized controlled trial

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 1, 2020

Actual Primary Completion Date :

Jul 30, 2021

Actual Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A 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 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
Placebo Comparator: Group B 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 patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table placebo by the patient 12 hours before the procedure

Arm

Intervention/Treatment

Experimental: Group A

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

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

Placebo Comparator: Group B

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

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

Outcome Measures

Primary Outcome Measures

Intensity of pain [15 minutes]
pain during the procedure assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable

Secondary Outcome Measures

Intensity of pain [30 minutes after the procedure]
Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

any patient came for Hysterosalpingography

Exclusion Criteria:

any patient has contraindication to HSG

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aswan University Hospital	Aswan		Egypt	81528

Sponsors and Collaborators

Aswan University Hospital

Investigators

Study Chair: nahla w Shady, md, Aswan universirty

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

hany farouk, A Professor, Aswan University Hospital

ClinicalTrials.gov Identifier:

NCT04500470

Other Study ID Numbers:

aswu/351/3/19

First Posted:

Aug 5, 2020

Last Update Posted:

Jan 19, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Infertility, Female

Ketoprofen

Study Results

No Results Posted as of Jan 19, 2022