Oral Hyoscine vs Lidocaine-Prilocaine Spray vs Placebo for HSG Pain Relief (NCT07383571) | Clinical Trial Compass
CompletedNot Applicable
Oral Hyoscine vs Lidocaine-Prilocaine Spray vs Placebo for HSG Pain Relief
Egypt102 participantsStarted 2025-10-03
Plain-language 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. Pain was self-rated using an 11-point numerical rating scale at predefined procedural time points, including cervical instrumentation and uterine filling.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain during cervical instrumentation
Timeframe: Within 1 minute after tenaculum placement and cervical cannulation, before contrast injection.