Lidocaine Prilocaine Spray in Reducing Pain During Hyster... | NCT06769204

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

NCT06769204

Sponsor

Cairo University

Status

Not yet recruiting

Last Update Posted

Jan 10, 2025Actual

Enrollment

90Estimated

Phase

Phase 3

Conditions

Infertility, Female

Interventions

EMLA SPRAY
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2025Estimated

Primary Completion Date

Aug 1, 2025Estimated

Completion Date

Aug 15, 2025Estimated

First Submitted Date

Jan 7, 2025

First Submission Date that Met QC Criteria

Jan 7, 2025

First Posted Date

Jan 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2025

Last Update Posted Date

Jan 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lidocaine prilocaine	Experimental		Drug: EMLA SPRAY
placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EMLA SPRAY	Drug	2 puffs of lidocaine-prilocaine spray into the cervix and cervical canal 5 minutes before the procedure	lidocaine prilocaine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
AHMED SAMY ALI ashour, MD	Contact	01100681167		ahmedsamy8233@gmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007247	Infertility, Female

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided