Ketoprofen With or Without Vaginal Isonicotinic Acid Hydrazide Prior to Hysterosalpingography

NCT ID: NCT04500470

Last Updated: 2022-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-09-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double blind placebo randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
double blind placebo randomized controlled trial

Study Groups

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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

Group Type EXPERIMENTAL

Ketoprofen + INH

Intervention Type 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 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

Group Type PLACEBO_COMPARATOR

Ketoprofen + placebo

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* any patient came for Hysterosalpingography

Exclusion Criteria

* any patient has contraindication to HSG
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aswan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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hany farouk

A Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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nahla w Shady, md

Role: STUDY_CHAIR

Aswan universirty

Locations

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Aswan University Hospital

Aswān, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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aswu/351/3/19

Identifier Type: -

Identifier Source: org_study_id

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