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NCT Number: NCT06769204

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

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

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EMLA SPRAY

Drug

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

Other names: 2 puffs into

Placebo

Drug

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

Primary outcomes

  1. pain during Cervical instrumentation of the tenaculum and cannula

    Time frame: 1 minute

    pain is measured using 10 cm VISUAL Analog scale where 0 denotes no pain and 10 maximum pain felt

Secondary outcomes

  1. pain At the end of uterine filling

    Time frame: 5 minutes

    pain is measured using 10 cm VISUAL Analog scale where 0 denotes no pain and 10 maximum pain felt

Study contacts

Contact information is provided by the study sponsor or research team.

AHMED SAMY ALI ashour, MD

CONTACT

[email protected]

01100681167

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 10, 2025
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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