NCT06769204

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2025

Shorter than P25 for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

February 10, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

January 7, 2025

Last Update Submit

January 7, 2025

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • pain At the end of uterine filling

    5 minutes

Study Arms (2)

lidocaine prilocaine

EXPERIMENTAL
Drug: EMLA SPRAY

placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

EMLA SPRAYDRUG

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

Also known as: 2 puffs into
lidocaine prilocaine
PlaceboDRUG

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

placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Central Study Contacts

AHMED SAMY ALI ashour, MD

CONTACT

01100681167ahmedsamy8233@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 7, 2025

First Posted

January 10, 2025

Study Start

February 10, 2025

Primary Completion

August 1, 2025

Study Completion

August 15, 2025

Last Updated

January 10, 2025

Record last verified: 2025-01