TerminatedPhase 4

Ibuprofen Versus Ketorolac for Pain Relief During Hysterosalpingogram

Stopped: IRB voted to terminate the protocol for noncompliance

United States12 participantsStarted 2022-03-24

Plain-language summary

Hysterosalpingogram (HSG) testing is a vital part of the workup for infertility patients. It is often noted to be biggest pain that patients undergo during the workup. Several studies have attempted to find a therapy that reduces pain, with non-steroidal anti-inflammatory drugs such as oral ibuprofen the current mainstay. Our study attempts to determine which of the following NSAIDS is best at reducing pain associated with the HSG procedure: oral ibuprofen versus oral ketorolac .

Who can participate

Age range

18 Years – 45 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: * English speaking * premenopausal females age 18-45 * patients currently undergoing HSG as part of routine work-up for infertility or subfertility, - - patients with negative urine pregnancy test within 24 hours of the scheduled procedure * patients having performance of HCG between menstrual cycle days 5-12n Exclusion Criteria: * Non-English speaking * patients with history of previous HSG performed * patients with contrast allergy or other contraindications to HSG * patients with contraindications to NSAID use * Patients with the following: * unwilling to consent * positive urine pregnancy test within 24 hours of the scheduled procedure * active renal or hepatic disease * chronic narcotic users * use of pain medications within 12 hours of the scheduled procedure * patients with chronic pain conditions (fibromyalgia, complex regional pain syndrome, etc.) * patients with unknown uterine anatomical pathology

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

Pain during contrast infiltration

Timeframe: Between 0 seconds and 5 minutes

Trial details

NCT IDNCT05190341

SponsorMadigan Army Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2024-10-10

View on ClinicalTrials.gov More Infertility, Female trials