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

Safety and Efficacy of Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women With Primary Infertility

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06769204

Enrollment

Registered

2025-01-10

Start date

2025-02-10

Completion date

2025-08-15

Last updated

2025-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Female

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.

Interventions

DRUGEMLA SPRAY

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Contacts

Primary ContactAHMED SAMY ALI ashour, MD

ahmedsamy8233@gmail.com01100681167

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026