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

Cairo University (CU)

Status and phase: Not yet enrolling; Phase 3

Conditions: Infertility, Female

Treatments: Drug: EMLA SPRAY; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06769204

LP SPRAY HSG

Details and patient eligibility

About

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

Full description

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

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

lidocaine prilocaine

Experimental group

Treatment:

Drug: EMLA SPRAY

placebo

Placebo Comparator group

Treatment:

Drug: Placebo