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Could a simple injection ease pain during fertility testing?

NCT ID NCT07048769

Symptom relief Sponsor: Montefiore Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study investigates whether a local anesthetic (lidocaine) injected near the cervix can reduce pain during a saline infusion sonogram, a routine fertility test that evaluates the uterus and fallopian tubes. About 246 women undergoing this procedure will be randomly assigned to receive either lidocaine or a sham block (a capped needle pressed without injection). Their self-reported pain scores will be compared to see if the anesthetic improves comfort.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lidocaine
What this could lead to
If effective, this could make saline infusion sonograms less painful and more accessible for women undergoing fertility evaluations.
What could go wrong
This is a single-site trial with 246 participants, and the benefit may be modest or not statistically significant. Lidocaine injections can cause temporary discomfort or rare side effects like allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 246 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pain during saline infusion sonogram

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Montefiore's Institute for Reproductive Medicine and Health

    RECRUITING

    Hartsdale, New York, 10530, United States