Diclofenac Potassium With or Without Vaginal Dinoprostone Prior to Hysterosalpingography

Aswan University Hospital

Status: Completed

Conditions: Infertility, Female

Treatments: Drug: diclofenac potassium + dinoprostone; Drug: diclofenac potassium + placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04500509

aswu/352/3/19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary infertility female came for HSG

Exclusion criteria

• any patient has contraindication to HSG

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Group A

Experimental group

Description:

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

Treatment:

Drug: diclofenac potassium + dinoprostone

Group B

Placebo Comparator group

Description:

patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal placebo 6 hours prior to the procedure

Treatment:

Drug: diclofenac potassium + placebo