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

NCT ID: NCT06769204

Last Updated: 2025-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-10

Study Completion Date

2025-08-15

Brief Summary

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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

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

Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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lidocaine prilocaine

Group Type EXPERIMENTAL

EMLA SPRAY

Intervention Type DRUG

2 puffs of lidocaine-prilocaine spray into the cervix and cervical canal 5 minutes before the procedure

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 puffs of saline into the cervix and cervical canal 5 minutes before the procedure

Interventions

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EMLA SPRAY

2 puffs of lidocaine-prilocaine spray into the cervix and cervical canal 5 minutes before the procedure

Intervention Type DRUG

Placebo

2 puffs of saline into the cervix and cervical canal 5 minutes before the procedure

Intervention Type DRUG

Other Intervention Names

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2 puffs into

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Samy aly ashour

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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AHMED SAMY ALI ashour, MD

Role: CONTACT

01100681167

Other Identifiers

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LP SPRAY HSG

Identifier Type: -

Identifier Source: org_study_id

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