Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women With Primary Infertility

Phase 3

Not yet recruiting

• Conditions: Infertility, Female
• Interventions: Drug: EMLA SPRAY; Drug: Placebo

• Registration Number: NCT06769204
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Study Start: 2025-02-10
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lidocaine prilocaine	EMLA SPRAY	-
placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
pain during Cervical instrumentation of the tenaculum and cannula	1 minute	pain is measured using 10 cm VISUAL Analog scale where 0 denotes no pain and 10 maximum pain felt

Secondary Outcome Measures

Name	Time	Method
pain At the end of uterine filling	5 minutes	pain is measured using 10 cm VISUAL Analog scale where 0 denotes no pain and 10 maximum pain felt