Infertility, FemaleNCT04518189
Transdermal Lidocaine for Pain Control During Hysterosalpingography
A study testing lidocaine patch in people with Infertility, Female, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
the study aims to investigate the effectiveness of Transdermal lidocaine patch for Pain Control During Hysterosalpingography 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?
- lidocaine patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- any patient came for Hysterosalpingography
Who cannot join
- any patient has contraindication to Hysterosalpingography
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aswan University Hospital
Aswān, 81528
Hany F Sallam, MD, 0122336052 ext. 002, hany.farouk@aswu.edu.eg
Nahla W Shady, MD, 01092440504 ext. 002, nahla.elsayed@aswu.edu.eg
About this study
Official title: Transdermal Lidocaine for Pain Control During Hysterosalpingography: A Randomized Controlled Trial
the study aims to investigate the effectiveness of Transdermal lidocaine patch for Pain Control During Hysterosalpingography
Read the detailed description
hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye
- Conditions
- Infertility, Female
- Being tested
- lidocaine patch, Sham patch
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine patchDrug
Also called Experimental
lidocaine patch applied 3 hours before the procedure
Sham patchDrug
Also called Placebo Comparator
Sham patch applied 3 hours before the procedure
| Study group | Role | What they receive |
|---|---|---|
| lidocaine patch | Experimental | 5% lidocaine patch applied at 3 hours before the procedure Receives: Drug: lidocaine patch |
| Sham patch | Placebo comparator | Sham patch containing no study medication applied 3 hours before the procedure Receives: Drug: Sham patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pain score during the procedure
Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Sep 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Aug 2021 (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.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind randomized trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany farouk, Aswan University Hospital
- Investigators
- nahla w Shady, md, Study chair, Aswan universirty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518189
- Sponsor's protocol ID
- aswu/295/3/19
- Status last verified
- Sep 2020
- First submitted
- 15 Aug 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdermal Lidocaine for Pain Control During Hysterosalpingography: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04518189
- Acronym / sponsor ID
- aswu/295/3/19
- Conditions
- Infertility, Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 19 Aug 2020 (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.
the study aims to investigate the effectiveness of Transdermal lidocaine patch for Pain Control During Hysterosalpingography
Detailed description
hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind randomized trial
| Arm | Type | Receives |
|---|---|---|
| lidocaine patch | Experimental | Drug: lidocaine patch5% lidocaine patch applied at 3 hours before the procedure |
| Sham patch | Placebo comparator | Drug: Sham patchSham patch containing no study medication applied 3 hours before the procedure |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- any patient came for Hysterosalpingography
Key exclusion criteria (1 listed)
- any patient has contraindication to Hysterosalpingography
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 |
|---|---|---|
| lidocaine patchAlso: Experimentallidocaine patch applied 3 hours before the procedure | Drug | lidocaine patch |
| Sham patchAlso: Placebo ComparatorSham patch applied 3 hours before the procedure | Drug | Sham patch |
Primary outcome
Mean pain score during the procedure
Time frame: 10 minutes
Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
nahla w Shady, md study chair
Aswan universirty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lidocaine patch in people with Infertility, Female, run by Aswan University Hospital at 1 site in Egypt.
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 1 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: status not confirmed, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hany f Sallam, md (+20102435461 ext. 002, hany.farouk@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean pain score during the procedure (time frame: 10 minutes). 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 21 Sep 2020; AzTrials last refreshed its copy on 6 Nov 2026.