Diclofenac Potassium With or Without Vaginal Dinoprostone Prior to Hysterosalpingography

Diclofenac Potassium With or Without Vaginal Dinoprostone Prior to Hysterosalpingography in Primarily Infertile Patients: a Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04500509

Enrollment

200

Registered

2020-08-05

Start date

2020-09-01

Completion date

2021-10-30

Last updated

2022-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Female

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.

Detailed description

hysterosalpingography is a diagnosis procedure in the evaluation of infertile women and considered to be the traditional and the gold standard in the assessment of the patency of the fallopian tubes. The major disadvantage of hysterosalpingography is pain. In a study reported the patients complained of moderate to severe pain during the procedure. It is reported that some patients undergoing hysterosalpingography was more stressful and anxiety and effect on pain scores.

Interventions

DRUGdiclofenac potassium + dinoprostone

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

DRUGdiclofenac potassium + placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

double blind placebo controlled trial

Intervention model description

double blind placebo controlled trial

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

* primary infertility female came for HSG

Exclusion criteria

* any patient has contraindication to HSG

Design outcomes

Primary

Measure	Time frame	Description
Mean pain score during hysterosalpigography by visual analog scale	15 minutes	pain during hysterosalpigography assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable

Secondary

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026