Paracervical block to reduce pain during saline infusion sonogram
Official title: Paracervical Block for Saline Infusion Sonogram in Fertility Evaluation: A Randomized Controlled Trial
Run by Montefiore Medical Center · NCT07048769 · Data updated 2026-11-12
This trial will test whether a lidocaine paracervical block reduces pain for women undergoing saline infusion sonograms during fertility evaluations.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 246 (estimated) |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (Hartsdale, New York) |
| Status | Recruiting |
| Started | July 2, 2025 |
| Main results expected | July 2027 |
| Study ends | July 2027 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT07048769 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women undergoing uterine cavity and tubal patency evaluation via saline infusion sonogram with a balloon catheter at Montefiore who can consent in English or Spanish, have taken 600–800 mg ibuprofen beforehand, and do not have a lidocaine allergy.
✕Probably not a fit
Patients having uterine-only evaluations, those who did not take the required ibuprofen pre-medication, or anyone with a known lidocaine allergy may not receive benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this randomized Phase 4 trial, 246 women having saline infusion sonograms with a balloon catheter for tubal patency at Montefiore will be assigned to receive either a lidocaine paracervical block or a sham procedure (capped needle pressed against the cervix). All participants are asked to take 600–800 mg ibuprofen 30 minutes to 4 hours before the procedure and will report pain scores at several points during and after the SIS. The investigators will compare self-reported pain ratings between groups to see if local anesthesia lowers procedural pain. Eligible participants must be able to consent in English or Spanish and have no known lidocaine allergy or other exclusion criteria.
Why it matters
Potential benefit: If successful, this could reduce pain during SIS and make fertility evaluations more comfortable and less likely to be avoided.
How similar studies have gone: Similar paracervical or local anesthesia approaches have reduced pain for procedures like IUD placement and surgical abortion, but evidence for use during saline infusion sonograms is limited and mixed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Undergoing uterine cavity and tubal patency evaluation via saline infusion sonogram with balloon catheter at Montefiore Institute for Reproductive Medicine and Health * Pre-medicated with 600-800 mg ibuprofen taken 30 minutes to 4 hours prior to procedure * Able to provide informed consent in English or Spanish * Capacity to consent Exclusion Criteria: * Undergoing uterine cavity evaluation only (without tubal patency assessment) * No ibuprofen pre-medication prior to procedure * Received misoprostol within 24 hours prior to procedure * Known allergy to lidocaine
Where it's running
-
Montefiore's Institute for Reproductive Medicine and Health
Hartsdale, New York, United States Recruiting
Study contacts
- Principal investigator: Julian Gingold, MD, PhD — Montefiore Medical Center
- Study coordinator: Meaghan Jain, MD
- Email: mejain@montefiore.org
- Phone: 781-439-5947
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.