HysterosalpingographyNCT07383571
Oral Hyoscine vs Lidocaine-Prilocaine Spray vs Placebo for HSG Pain Relief
A study of Hysterosalpingography, run by Cairo University at 1 site in Egypt.
Trial summary
This single-centre, three-arm, randomised, double-blind, double-dummy, placebo-controlled trial evaluated the efficacy and safety of oral hyoscine butylbromide, topical lidocaine-prilocaine spray and placebo for reducing pain during hysterosalpingography in women with primary infertility. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Hysterosalpingography
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Oct 2025to 30 Apr 2026
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18 to 40 years
- Primary infertility
- Scheduled to undergo hysterosalpingography as part of routine infertility evaluation
- Regular menstrual cycles
- Hysterosalpingography scheduled during the early proliferative phase of the menstrual cycle, days 6 to 12
- Negative urine pregnancy test on the day of the procedure
- Able to understand and use the 0 to 10 Numerical Rating Scale for Pain assessment
Who cannot join
- Secondary infertility
- Known hypersensitivity to hyoscine, lidocaine, or prilocaine
- Use of systemic analgesics, sedatives, or antispasmodics within 24 hours before hysterosalpingography
- Chronic pelvic pain or severe dysmenorrhoea requiring regular analgesia
- Active pelvic infection
- Known uterine anomaly
Show all 11Show fewer
- Cervical stenosis necessitating anaesthesia
- History of contrast allergy
- Inability to cooperate with numerical pain scoring
- Current pregnancy
- Severe systemic disease corresponding to American Society of Anesthesiologists physical status class III or higher
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Hyoscine Butylbromide Versus Topical Lidocaine-Prilocaine Spray Versus Placebo for Pain Relief During Hysterosalpingography: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial
This single-centre, three-arm, randomised, double-blind, double-dummy, placebo-controlled trial evaluated the efficacy and safety of oral hyoscine butylbromide, topical lidocaine-prilocaine spray and placebo for reducing pain during hysterosalpingography in women with primary infertility. Pain was self-rated using an 11-point numerical rating scale at predefined procedural time points, including cervical instrumentation and uterine filling.
Read the detailed description
This was a single-centre, three-arm, randomised, double-blind, double-dummy, placebo-controlled trial conducted at the Department of Obstetrics and Gynaecology, Al Gezeera Hospital, Giza, Egypt. Women aged 18-40 years with primary infertility scheduled for hysterosalpingography during the early proliferative phase of the menstrual cycle were randomly assigned in a 1:1:1 ratio to receive oral hyoscine butylbromide 20 mg with placebo cervical spray, topical lidocaine-prilocaine spray with placebo oral tablet, or double placebo. A double-dummy technique was used to preserve blinding across oral and topical routes of administration. Pain was assessed using a 0-10 numerical rating scale at predefined procedural time points. The primary outcome was pain during cervical instrumentation. Secondary outcomes included pain during uterine filling, pain after speculum insertion, pain 30 minutes after the procedure, patient satisfaction, rescue analgesia and adverse events.Before recruitment and randomisation of the first participant, the protocol was amended and approved by the Research Ethics Committee to specify the topical lidocaine-prilocaine spray formulation and the final outcome hierarchy described below. The registry record was subsequently updated during final study-data updating to reflect the approved amended protocol.
- Conditions
- Hysterosalpingography
- Being tested
- Oral Hyoscine butylbromide and Placebo Spray, Topical lidocaine-prilocaine spray and placebo oral tablet, Double Placebo
- Keywords
- hysterosalpingography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Hyoscine butylbromide and Placebo SprayDrug
Hyoscine butylbromide 20 mg oral tablet, single dose, administered 30 minutes before HSG, plus placebo cervical spray applied to the ectocervix and external cervical os 10 minutes before HSG.
Topical lidocaine-prilocaine spray and placebo oral tabletDrug
Topical lidocaine-prilocaine spray, Manovipercaine Plus, EVA Pharma, Egypt, containing lidocaine 15% and prilocaine 5%, applied as three sprays to the ectocervix and external cervical os 10 minutes before HSG, plus placebo oral tablet administered 30 minutes before HSG.
Double PlaceboDrug
Placebo oral tablet administered 30 minutes before HSG plus placebo cervical spray applied 10 minutes before HSG, at the same time points as the active interventions.
| Study group | Role | What they receive |
|---|---|---|
| Oral Hyoscine butylbromide and Placebo Spray | Experimental | Participants received a single 20 mg oral tablet of hyoscine butylbromide 30 minutes before hysterosalpingography, together with placebo cervical spray applied 10 minutes before the procedure. Receives: Drug: Oral Hyoscine butylbromide and Placebo Spray |
| Topical lidocaine-prilocaine spray and placebo oral tablet | Active comparator | Participants received topical lidocaine-prilocaine spray applied as three sprays to the ectocervix and external cervical os 10 minutes before hysterosalpingography, together with a placebo oral tablet given 30 minutes before the procedure. Receives: Drug: Topical lidocaine-prilocaine spray and placebo oral tablet |
| Double Placebo | Placebo comparator | Participants received a placebo oral tablet 30 minutes before HSG and placebo cervical spray applied to the ectocervix and external cervical os 10 minutes before the procedure. Receives: Drug: Double Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during cervical instrumentation
Pain intensity during cervical instrumentation, including tenaculum placement and cervical cannulation, measured using an 11-point numerical rating scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable
Measured: Within 1 minute after tenaculum placement and cervical cannulation, before contrast injection.
Secondary outcomes (7)
Pain after speculum insertion before cervical instrumentation
Pain intensity will be assessed immediately after speculum insertion and before tenaculum placement or cervical cannulation using the 11-point Numerical Rating Scale for Pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain intensity.
Measured: Intra-procedure, immediately after speculum insertion and before cervical instrumentation.
Pain 30 minutes after HSG
Pain intensity will be assessed 30 minutes after completion of hysterosalpingography using the 11-point Numerical Rating Scale for Pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain intensity.
Measured: 30 minutes post-procedure
Patient satisfaction 30 minutes after HSG
Patient satisfaction with the procedure, measured using a 0-10 satisfaction scale, where 0 indicates no satisfaction and 10 indicates maximum satisfaction.
Measured: 30 minutes postprocedure
Pain during uterine filling
Pain intensity during or immediately after contrast injection at the end of uterine filling, measured using an 11-point numerical rating scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Measured: During HSG, at the end of uterine filling / immediately after contrast injection.
Post-procedure rescue analgesia
Number and percentage of participants requiring rescue analgesia after completion of the 30-minute post-procedure pain assessment. Rescue analgesia consisted of oral paracetamol 1,000 mg.
Measured: After the 30-minute post-procedure pain assessment.
Adverse events related to study medications or hysterosalpingography
Adverse events will be reported as the number and percentage of participants experiencing any adverse event potentially related to the study medications or the hysterosalpingography procedure. Events assessed will include dry mouth, nausea, dizziness, blurred vision, tachycardia, vasovagal reaction, allergic symptoms, local irritation or burning, and any other unexpected adverse event.
Measured: Periprocedural: during hysterosalpingography and up to 30 minutes after completion of the procedure.
Serious adverse events related to study medications or hysterosalpingography
Serious adverse events will be reported as the number and percentage of participants experiencing any serious adverse event during or after hysterosalpingography, including events requiring urgent medical intervention, hospital referral, or prolonged medical observation.
Measured: Periprocedural: during hysterosalpingography and up to 30 minutes after completion of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start3 Oct 2025
- Primary completion1 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterosalpingographyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Aljazeera Hospital
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
- Investigators
- Mahmoud Alalfy, MD, Principal investigator, Algezeera Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383571
- Sponsor's protocol ID
- HSG-Analgesia-2025
- Status last verified
- Jun 2026
- First submitted
- 21 Sep 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- 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 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Hyoscine Butylbromide Versus Topical Lidocaine-Prilocaine Spray Versus Placebo for Pain Relief During Hysterosalpingography: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07383571
- Acronym / sponsor ID
- HSG-Analgesia-2025
- Conditions
- Hysterosalpingography
- Keywords
- hysterosalpingography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Aljazeera Hospital
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 3 Feb 2026 (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.
This single-centre, three-arm, randomised, double-blind, double-dummy, placebo-controlled trial evaluated the efficacy and safety of oral hyoscine butylbromide, topical lidocaine-prilocaine spray and placebo for reducing pain during hysterosalpingography in women with primary infertility. Pain was self-rated using an 11-point numerical rating scale at predefined procedural time points, including cervical instrumentation and uterine filling.
Detailed description
This was a single-centre, three-arm, randomised, double-blind, double-dummy, placebo-controlled trial conducted at the Department of Obstetrics and Gynaecology, Al Gezeera Hospital, Giza, Egypt. Women aged 18-40 years with primary infertility scheduled for hysterosalpingography during the early proliferative phase of the menstrual cycle were randomly assigned in a 1:1:1 ratio to receive oral hyoscine butylbromide 20 mg with placebo cervical spray, topical lidocaine-prilocaine spray with placebo oral tablet, or double placebo. A double-dummy technique was used to preserve blinding across oral and topical routes of administration. Pain was assessed using a 0-10 numerical rating scale at predefined procedural time points. The primary outcome was pain during cervical instrumentation. Secondary outcomes included pain during uterine filling, pain after speculum insertion, pain 30 minutes after the procedure, patient satisfaction, rescue analgesia and adverse events.Before recruitment and randomisation of the first participant, the protocol was amended and approved by the Research Ethics Committee to specify the topical lidocaine-prilocaine spray formulation and the final outcome hierarchy described below. The registry record was subsequently updated during final study-data updating to reflect the approved amended protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Hyoscine butylbromide and Placebo Spray | Experimental | Drug: Oral Hyoscine butylbromide and Placebo SprayParticipants received a single 20 mg oral tablet of hyoscine butylbromide 30 minutes before hysterosalpingography, together with placebo cervical spray applied 10 minutes before the procedure. |
| Topical lidocaine-prilocaine spray and placebo oral tablet | Active comparator | Drug: Topical lidocaine-prilocaine spray and placebo oral tabletParticipants received topical lidocaine-prilocaine spray applied as three sprays to the ectocervix and external cervical os 10 minutes before hysterosalpingography, together with a placebo oral tablet given 30 minutes before the procedure. |
| Double Placebo | Placebo comparator | Drug: Double PlaceboParticipants received a placebo oral tablet 30 minutes before HSG and placebo cervical spray applied to the ectocervix and external cervical os 10 minutes before the procedure. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women aged 18 to 40 years
- Primary infertility
- Scheduled to undergo hysterosalpingography as part of routine infertility evaluation
- Regular menstrual cycles
- Hysterosalpingography scheduled during the early proliferative phase of the menstrual cycle, days 6 to 12
Key exclusion criteria (11 listed)
- Secondary infertility
- Known hypersensitivity to hyoscine, lidocaine, or prilocaine
- Use of systemic analgesics, sedatives, or antispasmodics within 24 hours before hysterosalpingography
- Chronic pelvic pain or severe dysmenorrhoea requiring regular analgesia
- Active pelvic infection
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 |
|---|---|---|
| Oral Hyoscine butylbromide and Placebo SprayHyoscine butylbromide 20 mg oral tablet, single dose, administered 30 minutes before HSG, plus placebo cervical spray applied to the ectocervix and external cervical os 10 minutes before HSG. | Drug | Oral Hyoscine butylbromide and Placebo Spray |
| Topical lidocaine-prilocaine spray and placebo oral tabletTopical lidocaine-prilocaine spray, Manovipercaine Plus, EVA Pharma, Egypt, containing lidocaine 15% and prilocaine 5%, applied as three sprays to the ectocervix and external cervical os 10 minutes before HSG, plus placebo oral tablet administered 30 minutes before HSG. | Drug | Topical lidocaine-prilocaine spray and placebo oral tablet |
| Double PlaceboPlacebo oral tablet administered 30 minutes before HSG plus placebo cervical spray applied 10 minutes before HSG, at the same time points as the active interventions. | Drug | Double Placebo |
Primary outcome
Pain during cervical instrumentation
Time frame: Within 1 minute after tenaculum placement and cervical cannulation, before contrast injection.
Pain intensity during cervical instrumentation, including tenaculum placement and cervical cannulation, measured using an 11-point numerical rating scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable
7 secondary outcomes
Pain after speculum insertion before cervical instrumentation
Time frame: Intra-procedure, immediately after speculum insertion and before cervical instrumentation.
Pain 30 minutes after HSG
Time frame: 30 minutes post-procedure
Patient satisfaction 30 minutes after HSG
Time frame: 30 minutes postprocedure
Pain during uterine filling
Time frame: During HSG, at the end of uterine filling / immediately after contrast injection.
Post-procedure rescue analgesia
Time frame: After the 30-minute post-procedure pain assessment.
Adverse events related to study medications or hysterosalpingography
Time frame: Periprocedural: during hysterosalpingography and up to 30 minutes after completion of the procedure.
Serious adverse events related to study medications or hysterosalpingography
Time frame: Periprocedural: during hysterosalpingography and up to 30 minutes after completion of the procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Hysterosalpingography
Not yet recruitingPhase 4
Pain Control During Hysterosalpingography: A Three-Arm Randomized Trial
Hysterosalpingography-Related Pain
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The Hysterosalpingogram (HSG) Experience And Tubal Spasm (HEAT) Study
Infertility
Not yet recruiting
Effect of Music in Reducing Pain and Anxiety During Hysterosalpingography in Women With Primary Infertility
Pain
Not yet recruitingPhase 3
Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women With Primary Infertility
Infertility, Female
Active, not recruitingObservational study
Comparison of Ultrasound and Hysterosalpingography in Evaluation of Uterine Abnormality in Patients With Infertility
Uterine Abnormality
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.
Mahmoud Alalfy, MD principal investigator
Algezeera Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hysterosalpingography, run by Cairo University 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 7 inclusion and 11 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: finished, as of the sponsor's last update on 11 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during cervical instrumentation (time frame: Within 1 minute after tenaculum placement and cervical cannulation, before contrast injection.). 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 11 Jun 2026.