Infertility, FemalePhase 3NCT06769204
Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women With Primary Infertility
A Phase 3 study testing EMLA SPRAY in people with Infertility, Female, run by Cairo University.
Trial summary
We aim to assess the Safety and Efficacy of Cervical Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in women with primary infertility Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- EMLA SPRAY
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2025to 15 Aug 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Efficacy of 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
Read the 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.
- Conditions
- Infertility, Female
- Being tested
- EMLA SPRAY, Placebo
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMLA SPRAYDrug
Also called 2 puffs into
2 puffs of lidocaine-prilocaine spray into the cervix and cervical canal 5 minutes before the procedure
PlaceboDrug
2 puffs of saline into the cervix and cervical canal 5 minutes before the procedure
| Study group | Role | What they receive |
|---|---|---|
| lidocaine prilocaine | Experimental | Not described Receives: Drug: EMLA SPRAY |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 minute
Secondary outcomes (1)
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
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start10 Feb 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769204
- Sponsor's protocol ID
- LP SPRAY HSG
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 10 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women With Primary Infertility
- ClinicalTrials.gov ID
- NCT06769204
- Acronym / sponsor ID
- LP SPRAY HSG
- Conditions
- Infertility, Female
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Feb 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine prilocaine | Experimental | Drug: EMLA SPRAY |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMLA SPRAYAlso: 2 puffs into2 puffs of lidocaine-prilocaine spray into the cervix and cervical canal 5 minutes before the procedure | Drug | lidocaine prilocaine |
| Placebo2 puffs of saline into the cervix and cervical canal 5 minutes before the procedure | Drug | placebo |
Primary outcome
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
1 secondary outcome
pain At the end of uterine filling
Time frame: 5 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EMLA SPRAY in people with Infertility, Female, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AHMED SAMY ALI ashour, MD (01100681167, ahmedsamy8233@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain during Cervical instrumentation of the tenaculum and cannula (time frame: 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.