Infertility, FemalePhase 4NCT05190341
Ibuprofen Versus Ketorolac for Pain Relief During Hysterosalpingogram
A Phase 4 study testing Ibuprofen 800 mg oral and Ketorolac 30mg oral in people with Infertility, Female, run by Madigan Army Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Ibuprofen 800 mg oral and Ketorolac 30mg oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2022to 10 Oct 2024
- Phase
- Phase 4
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
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 .
Read the detailed description
Describe step-by-step how the study will be conducted from beginning to end
- After IRB approval, the research pharmacist will provide motrin and ketorolac in identical packets labeled 1-88, after receiving the randomization strategy/number set from the research monitor.
- REI physician on the protocol will screen patient for inclusion/exclusion from study at new patient consult or at future follow up visit when need for HSG is decided.
- If patient pt screens eligible, discuss study. If elects participation then consent patient and randomize to group.
- At time of scheduling HSG, patient will need to remind nursing that they are in HSG study. Nursing should also have the list of patients to reference when scheduling HSGs. Patients in the study will need to check in at the REI clinic 70 minutes prior to HSG in order to take their meds 60 minutes prior to scheduled procedure time. At same visit, REI RN will perform urine pregnancy test as previously scheduled.
- meds will be kept in a locked cabinet in the REI research office in opaque sealed envelopes.
- Patient will then go check into Radiology for their HSG.
- HSG will be performed per standard clinical protocol. The HSG will be performed by REI physicians and OB/GYN residents (who are rotating on REI), which are the current standard of practice.
- A nurse or provider associated with the study will need to be at the HSG for the sole purpose of study assistance. The provider performing the HSG, the study personnel recording pain levels, and the fluro tech will not be aware of the type of pre-procedural medication the patient received. The nurse or provider of study personnel will do the following:
- time the procedure from placement of speculum through deflation of catheter balloon and removal of catheter. Record time in seconds (can write mins:seconds and then convert later).
- record who performed the procedure, if a tenaculum had to be used, and if an attending had to take over the procedure
- help patient record pain scale marks on the VAS sheet at the designated time periods.
- For clarity- there will be at least three providers at each HSG for study enrolled patients.
- A provider who does the HSG
- A fluoro technician to capture fluoro images for teh HSG
- A study affialitied person to record pain scores for patient as above 8. At the conclusion of study recruitment, the blinded researchers will gain access to the subject ID's cohort status (ibuprofen vs ketorolac), and study analysis will be undertaken.
- Conditions
- Infertility, Female
- Being tested
- Ibuprofen 800 mg oral, Ketorolac 30mg oral
- Keywords
- hysterosalpingogram, ibuprofen, ketorolac
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 800 mg oralDrug
Also called Advil, Motrin
1 hour before HSG
Ketorolac 30mg oralDrug
Also called Toradol
1 hour before HSG
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Experimental | Patients randomized to this arm will receive an identical capsule to the other patient arm, and receive 800mg ibuprofen 1 hour before HSG. Receives: Drug: Ibuprofen 800 mg oral |
| Ketorolac | Experimental | Patients randomized to this arm will receive an identical capsule to the other patient arm, and receive 30mg ketorolac 1 hour before HSG. Receives: Drug: Ketorolac 30mg oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during contrast infiltration
Pain on Visual Analogue Scale (0-100)
Measured: Between 0 seconds and 5 minutes
Secondary outcomes (4)
Pain at baseline (before procedure start)
Pain on Visual Analogue Scale (0-100)
Measured: Between 0 seconds and 5 minutes
Pain with HSG catheter placement
Pain on Visual Analogue Scale (0-100)
Measured: Between 0 seconds and 5 minutes
Pain at completion of HSG
Pain on Visual Analogue Scale (0-100)
Measured: Between 0 seconds and 5 minutes
Pain 5 minutes following HSG
Pain on Visual Analogue Scale (0-100)
Measured: 5 minutes after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start24 Mar 2022
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Why it stopped: IRB voted to terminate the protocol for noncompliance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized controlled trial- 88 sequential patients randomized to receive either ibuprofen on ketorolac 1 hr before HSG
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madigan Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Bruce Pier, Principal investigator, Madigan Chief of REI, Department of OBGYN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190341
- Sponsor's protocol ID
- 221063
- Status last verified
- Dec 2024
- First submitted
- 29 Oct 2021
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibuprofen Versus Ketorolac for Pain Relief During Hysterosalpingogram
- ClinicalTrials.gov ID
- NCT05190341
- Acronym / sponsor ID
- 221063
- Conditions
- Infertility, Female
- Keywords
- hysterosalpingogram, ibuprofen, ketorolac
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB voted to terminate the protocol for noncompliance
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Madigan Army Medical CenterUS federal agency
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 13 Jan 2022 (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.
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 .
Detailed description
Describe step-by-step how the study will be conducted from beginning to end
- After IRB approval, the research pharmacist will provide motrin and ketorolac in identical packets labeled 1-88, after receiving the randomization strategy/number set from the research monitor.
- REI physician on the protocol will screen patient for inclusion/exclusion from study at new patient consult or at future follow up visit when need for HSG is decided.
- If patient pt screens eligible, discuss study. If elects participation then consent patient and randomize to group.
- At time of scheduling HSG, patient will need to remind nursing that they are in HSG study. Nursing should also have the list of patients to reference when scheduling HSGs. Patients in the study will need to check in at the REI clinic 70 minutes prior to HSG in order to take their meds 60 minutes prior to scheduled procedure time. At same visit, REI RN will perform urine pregnancy test as previously scheduled.
- meds will be kept in a locked cabinet in the REI research office in opaque sealed envelopes.
- Patient will then go check into Radiology for their HSG.
- HSG will be performed per standard clinical protocol. The HSG will be performed by REI physicians and OB/GYN residents (who are rotating on REI), which are the current standard of practice.
- A nurse or provider associated with the study will need to be at the HSG for the sole purpose of study assistance. The provider performing the HSG, the study personnel recording pain levels, and the fluro tech will not be aware of the type of pre-procedural medication the patient received. The nurse or provider of study personnel will do the following:
- time the procedure from placement of speculum through deflation of catheter balloon and removal of catheter. Record time in seconds (can write mins:seconds and then convert later).
- record who performed the procedure, if a tenaculum had to be used, and if an attending had to take over the procedure
- help patient record pain scale marks on the VAS sheet at the designated time periods.
- For clarity- there will be at least three providers at each HSG for study enrolled patients.
- A provider who does the HSG
- A fluoro technician to capture fluoro images for teh HSG
- A study affialitied person to record pain scores for patient as above 8. At the conclusion of study recruitment, the blinded researchers will gain access to the subject ID's cohort status (ibuprofen vs ketorolac), and study analysis will be undertaken.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized controlled trial- 88 sequential patients randomized to receive either ibuprofen on ketorolac 1 hr before HSG
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Experimental | Drug: Ibuprofen 800 mg oralPatients randomized to this arm will receive an identical capsule to the other patient arm, and receive 800mg ibuprofen 1 hour before HSG. |
| Ketorolac | Experimental | Drug: Ketorolac 30mg oralPatients randomized to this arm will receive an identical capsule to the other patient arm, and receive 30mg ketorolac 1 hour before HSG. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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:
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 |
|---|---|---|
| Ibuprofen 800 mg oralAlso: Advil, Motrin1 hour before HSG | Drug | Ibuprofen |
| Ketorolac 30mg oralAlso: Toradol1 hour before HSG | Drug | Ketorolac |
Primary outcome
Pain during contrast infiltration
Time frame: Between 0 seconds and 5 minutes
Pain on Visual Analogue Scale (0-100)
4 secondary outcomes
Pain at baseline (before procedure start)
Time frame: Between 0 seconds and 5 minutes
Pain with HSG catheter placement
Time frame: Between 0 seconds and 5 minutes
Pain at completion of HSG
Time frame: Between 0 seconds and 5 minutes
Pain 5 minutes following HSG
Time frame: 5 minutes after procedure
Results and safety
The study was stopped early (reason given: IRB voted to terminate the protocol for noncompliance). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Infertility, Female
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Not yet recruitingObservational study
Linzagolix in Adenomyosis and Recurrent Implantation Failure
Adenomyosis of Uterus, Implantation Failure
Not yet recruitingObservational study
Low TGF-β and Embryo Implantation in the Context of Assisted Reproductive Technology: Confirmation of a Biomarker Predictive of Success and Characterization of the Immune Microenvironment.
Infertility, Female, Pregnancy Related
RecruitingObservational study
The Effects of Uterine Fibroids on Pregnancy in Women
Female Infertility, Uterine Fibroid
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.
Bruce Pier principal investigator
Madigan Chief of REI, Department of OBGYN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen 800 mg oral and Ketorolac 30mg oral in people with Infertility, Female, run by Madigan Army Medical Center at 1 site in United States.
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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 24 Dec 2024. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: IRB voted to terminate the protocol for noncompliance). Results are not available in the source record.
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 contrast infiltration (time frame: Between 0 seconds and 5 minutes). 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 24 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.