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Clinical Trials/NCT06769204
NCT06769204
Not yet recruiting
Phase 3

Safety and Efficacy of Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women With Primary Infertility

Cairo University0 sites90 target enrollmentFebruary 10, 2025

Overview

Phase
Phase 3
Intervention
EMLA SPRAY
Conditions
Infertility, Female
Sponsor
Cairo University
Enrollment
90
Primary Endpoint
pain during Cervical instrumentation of the tenaculum and cannula
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

We aim to assess the Safety and Efficacy of Cervical Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in women with primary infertility

Detailed Description

We aim to assess the Safety and Efficacy of Cervical Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women with Primary Infertility.

Registry
clinicaltrials.gov
Start Date
February 10, 2025
End Date
August 15, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Samy aly ashour

professor

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Women aged 18-45 years. Diagnosed with primary infertility (no prior pregnancy after at least 12 months of unprotected intercourse) and scheduled for HSG as part of infertility evaluation.

Exclusion Criteria

  • Known allergy or hypersensitivity to lidocaine, prilocaine, or any components of the spray.
  • Current pregnancy or suspicion of pregnancy.
  • Active pelvic inflammatory disease or history of severe pelvic infections within the last 6 months.
  • Use of systemic analgesics, sedatives, or anesthetics within 24 hours prior to the procedure.

Arms & Interventions

lidocaine prilocaine

Intervention: EMLA SPRAY

placebo

Intervention: Placebo

Outcomes

Primary Outcomes

pain during Cervical instrumentation of the tenaculum and cannula

Time Frame: 1 minute

pain is measured using 10 cm VISUAL Analog scale where 0 denotes no pain and 10 maximum pain felt

Secondary Outcomes

  • pain At the end of uterine filling(5 minutes)

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