Infertility (IVF Patients)Phase 4NCT07185724
Ketorolac Use and Fresh Embryo Transfer Outcomes
A Phase 4 study testing Ketorolac 30 mg IV in people with Infertility (IVF Patients) and Infertility Treatment, run by Jessica D. Kresowik at 1 site in United States.
Trial summary
Ketorolac is a medication often used to relieve pain after surgery. In the past, infertility doctors have been cautious about using ketorolac after egg retrieval for patients planning a fresh embryo transfer (usually done 5 days later). Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Infertility (IVF Patients), Infertility Treatment, Post-op Pain
- What is being tested?
- Ketorolac 30 mg IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2025to 1 Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- IVF utilizing autologous oocytes and all sperm sources
- IVF cycles utilizing ICSI and standard insemination
- Plan to transfer embryo on day 5
- BMI below 50
Who cannot join
- -allergies or medical contraindications to NSAIDs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UI Health Care Center for Advanced Reproductive Care
Iowa City, Iowa, 52245
Aya Iwamoto, MD, (319) 356-1767, aya-iwamoto@uiowa.edu
Jessica Kresowik
About this study
Official title: Balancing Comfort and Success: Post-retrieval Ketorolac in Fresh Embryo Transfers
Ketorolac is a medication often used to relieve pain after surgery. In the past, infertility doctors have been cautious about using ketorolac after egg retrieval for patients planning a fresh embryo transfer (usually done 5 days later). The concern was that ketorolac might increase the risk of bleeding or reduce the chances of the embryo implanting in the uterus. This concern comes from how ketorolac works-it blocks certain chemicals in the body (like prostaglandins and thromboxane) that help with blood clotting and play a role in early pregnancy.
However, a large review of past studies found no real evidence that ketorolac increases bleeding risk. In fact, ketorolac is now routinely used for pain relief in IVF cycles where embryos are frozen and not transferred right away. More recent studies from Boston and Chapel Hill have shown that ketorolac provides better pain control and does not appear to harm IVF outcomes, even when embryos are transferred fresh (within the same cycle).
Read more
Despite these encouraging findings, many IVF clinics still avoid using ketorolac during fresh cycles because of the theoretical concerns. That's why we need stronger, higher-quality research.
This study aims to fill that gap by conducting a double-blind randomized controlled trial to find out whether giving ketorolac through an IV after egg retrieval affects important IVF outcomes-especially the chance of implantation and live birth-in patients undergoing fresh embryo transfers. Patients who choose to join the study will randomly be placed into one of two groups. One group will get ketorolac (a pain medicine) after an IVF egg retrieval. The other group will not get ketorolac after egg retrieval. Everything else in their IVF care will stay the same as it normally would.
Primary outcome will be implantation rate following fresh embryo transfers in patients receiving ketorolac (30mg IV) vs no ketorolac for post-retrieval analgesia.
Secondary outcomes will include pain scale, narcotics required, time to discharge, need for evaluation w/in 24 hours for pain/bleeding, clinical pregnancy rates, miscarriage rates, and live birth rates following fresh embryo transfers in patients receiving ketorolac vs no ketorolac for post-retrieval analgesia.
Read the detailed description
Study Design: double-blind randomized controlled trial Intervention: Ketorolac (30mg intravenous) administration in the immediate post-operative period prior to leaving the procedure room and while patient is still under sedation
Allocation method: 1:1 statistician generated block randomization (blocks of 2, 4, and 6). Patients will be randomized immediately following consent and enrollment.
Materials and Methods: Patients undergoing an IVF autologous cycle at our institution where the female patient is planning on proceeding with a fresh embryo transfer 5 days following ultrasound guided oocyte retrieval will be recruited. Patients may undergo any of our standard controlled ovarian hyperstimulation protocols.
On the day of egg retrieval patients will:
- Sign the consent and be randomly assigned to one of two groups (usual care plus ketorolac OR usual care without ketorolac).
- At the end of the retrieval procedure while the patient is still under sedation, the anesthesiology team will administer either usual care plus ketorolac OR usual care without ketorolac through the pre-existing IV line.
Patients IVF care will otherwise remain the same as planned, including:
- Monitoring in the recovery area as per standard protocol
- Embryo transfer on day 5 post-retrieval
Investigators will continue to review and collect data from patients' medical records for up to 45 weeks. This will include demographic and medical information, including, but not limited to:
- age, medical diagnosis, physical exam findings such as height and weight, laboratory testing, and ultrasound results
- reproductive history including how long patients have been trying to conceive, infertility diagnoses, outcomes of past pregnancies, outcomes of prior infertility evaluation and treatments
- the types and doses of medications used, types of infertility treatments used, and information about patients' treatment cycles. Treatment cycle information will include, but is not limited to:
- response to ovarian stimulation,
- sperm count,
- embryo development and quality,
- any post-retrieval evaluations for pain and/or bleeding, and
- whether or not a pregnancy resulted.
- narcotic use during recovery, and time to discharge
- Outcomes from the fresh embryo transfer following retrieval. If patients conceive a pregnancy, then investigators will follow the pregnancy through its resolution. Investigators will collect information about patients:
- pregnancy hormone levels,
- confirmation or pregnancy ultrasound findings,
- information on implantation, clinical pregnancy, miscarriage, and live births.
- Conditions
- Infertility (IVF Patients), Infertility Treatment, Post-op Pain, Fresh Embryo Transfer, Oocyte Retrieval and Post Operative Pain Control
- Being tested
- Ketorolac 30 mg IV
- Keywords
- IVF, post operative pain control, oocyte retrieval, fresh embryo transfer, ketorolac, toradol, implantation rate, live birth rate, miscarriage rate
- Medical subject headings
- Infertility, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac 30 mg IVDrug
We will be evaluating the effect of post-oocyte retrieval ketorolac administration on clinical outcomes in fresh embryo transfer cycles.
| Study group | Role | What they receive |
|---|---|---|
| IV Ketorolac | Experimental | Participants randomized to this arm will receive 30mg IV Ketorolac at the conclusion of their oocyte retrieval. Receives: Drug: Ketorolac 30 mg IV |
| No IV Ketorolac | No intervention | Participants randomized to this arm will not receive IV Ketorolac at the conclusion of their oocyte retrieval. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation Rate
Implantation rate following fresh embryo transfers in patients receiving ketorolac vs no ketorolac for post-retrieval analgesia. We define implantation rate as the proportion of transferred embryos which resulted in fetal heartbeat seen on ultrasound per patient.
Measured: From enrollment to the time of confirmation of pregnancy ultrasound at ~6 weeks post-oocyte retrieval (with or without administration of IV Ketorolac) .
Secondary outcomes (4)
Clinical Pregnancy Rate
Clinical pregnancy rate is defined as the proportion of patients who had an embryo transfer which resulted in a pregnancy confirmed by an increasing level of human Chorionic Gonadotropin (hCG) and the presence of a gestational sac detected by ultrasound.
Measured: From enrollment to the time of confirmation of pregnancy ultrasound at ~6 weeks post-oocyte retrieval (with or without administration of IV Ketorolac) .
Miscarriage Rate
Miscarriage rate is defined as the percentage of patients with miscarriage after a clinical pregnancy.
Measured: From date of enrollment through first documented instance of miscarriage up to 40 weeks.
Live Birth Rate
Live birth rate is defined as percentage of patients who had a transfer which resulted in a live birth.
Measured: From enrollment to the end of pregnancy (~40 weeks) resulting from fresh embryo transfer following the oocyte retrieval in which patient received IV Ketorolac or no IV Ketorolac.
Post-operative Pain
In the immediate post-operative period, pain will be assessed per standard practice using the visual analog scale. The visual analog scale is used to assess pain on a scale of 0 to 10 with 0 being no pain and 10 being worst pain.
Measured: From enrollment until the time of discharge from oocyte retrieval (~2.5 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start8 Nov 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infertility (IVF Patients)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jessica D. Kresowik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jessica D. Kresowik, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185724
- Sponsor's protocol ID
- 202505454
- Status last verified
- Dec 2025
- First submitted
- 10 Sep 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Mesen TB, Kacemi-Bourhim L, Marshburn PB, Usadi RS, Matthews M, Norton HJ, Hurst BS. The effect of ketorolac on pregnancy rates when used immediately after oocyte retrieval. Fertil Steril. 2013 Sep;100(3):725-8. doi: 10.1016/j.fertnstert.2013.04.048. Epub 2013 May 28.
PubMed 23721715Gobble RM, Hoang HLT, Kachniarz B, Orgill DP. Ketorolac does not increase perioperative bleeding: a meta-analysis of randomized controlled trials. Plast Reconstr Surg. 2014 Mar;133(3):741-755. doi: 10.1097/01.prs.0000438459.60474.b5.
PubMed 24572864Waljee JF, Li L, Brummett CM, Englesbe MJ. Iatrogenic Opioid Dependence in the United States: Are Surgeons the Gatekeepers? Ann Surg. 2017 Apr;265(4):728-730. doi: 10.1097/SLA.0000000000001904. No abstract available.
PubMed 27429023
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balancing Comfort and Success: Post-retrieval Ketorolac in Fresh Embryo Transfers
- ClinicalTrials.gov ID
- NCT07185724
- Acronym / sponsor ID
- 202505454
- Conditions
- Infertility (IVF Patients), Infertility Treatment, Post-op Pain, Fresh Embryo Transfer, Oocyte Retrieval and Post Operative Pain Control
- Keywords
- IVF, post operative pain control, oocyte retrieval, fresh embryo transfer, ketorolac, toradol, implantation rate, live birth rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jessica D. KresowikUniversity, hospital or other
- Study start
- 8 Nov 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 22 Sep 2025 (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.
Ketorolac is a medication often used to relieve pain after surgery. In the past, infertility doctors have been cautious about using ketorolac after egg retrieval for patients planning a fresh embryo transfer (usually done 5 days later). The concern was that ketorolac might increase the risk of bleeding or reduce the chances of the embryo implanting in the uterus. This concern comes from how ketorolac works-it blocks certain chemicals in the body (like prostaglandins and thromboxane) that help with blood clotting and play a role in early pregnancy.
However, a large review of past studies found no real evidence that ketorolac increases bleeding risk. In fact, ketorolac is now routinely used for pain relief in IVF cycles where embryos are frozen and not transferred right away. More recent studies from Boston and Chapel Hill have shown that ketorolac provides better pain control and does not appear to harm IVF outcomes, even when embryos are transferred fresh (within the same cycle).
Despite these encouraging findings, many IVF clinics still avoid using ketorolac during fresh cycles because of the theoretical concerns. That's why we need stronger, higher-quality research.
This study aims to fill that gap by conducting a double-blind randomized controlled trial to find out whether giving ketorolac through an IV after egg retrieval affects important IVF outcomes-especially the chance of implantation and live birth-in patients undergoing fresh embryo transfers. Patients who choose to join the study will randomly be placed into one of two groups. One group will get ketorolac (a pain medicine) after an IVF egg retrieval. The other group will not get ketorolac after egg retrieval. Everything else in their IVF care will stay the same as it normally would.
Primary outcome will be implantation rate following fresh embryo transfers in patients receiving ketorolac (30mg IV) vs no ketorolac for post-retrieval analgesia.
Secondary outcomes will include pain scale, narcotics required, time to discharge, need for evaluation w/in 24 hours for pain/bleeding, clinical pregnancy rates, miscarriage rates, and live birth rates following fresh embryo transfers in patients receiving ketorolac vs no ketorolac for post-retrieval analgesia.
Detailed description
Study Design: double-blind randomized controlled trial Intervention: Ketorolac (30mg intravenous) administration in the immediate post-operative period prior to leaving the procedure room and while patient is still under sedation
Allocation method: 1:1 statistician generated block randomization (blocks of 2, 4, and 6). Patients will be randomized immediately following consent and enrollment.
Materials and Methods: Patients undergoing an IVF autologous cycle at our institution where the female patient is planning on proceeding with a fresh embryo transfer 5 days following ultrasound guided oocyte retrieval will be recruited. Patients may undergo any of our standard controlled ovarian hyperstimulation protocols.
On the day of egg retrieval patients will:
- Sign the consent and be randomly assigned to one of two groups (usual care plus ketorolac OR usual care without ketorolac).
- At the end of the retrieval procedure while the patient is still under sedation, the anesthesiology team will administer either usual care plus ketorolac OR usual care without ketorolac through the pre-existing IV line.
Patients IVF care will otherwise remain the same as planned, including:
- Monitoring in the recovery area as per standard protocol
- Embryo transfer on day 5 post-retrieval
Investigators will continue to review and collect data from patients' medical records for up to 45 weeks. This will include demographic and medical information, including, but not limited to:
- age, medical diagnosis, physical exam findings such as height and weight, laboratory testing, and ultrasound results
- reproductive history including how long patients have been trying to conceive, infertility diagnoses, outcomes of past pregnancies, outcomes of prior infertility evaluation and treatments
- the types and doses of medications used, types of infertility treatments used, and information about patients' treatment cycles. Treatment cycle information will include, but is not limited to:
- response to ovarian stimulation,
- sperm count,
- embryo development and quality,
- any post-retrieval evaluations for pain and/or bleeding, and
- whether or not a pregnancy resulted.
- narcotic use during recovery, and time to discharge
- Outcomes from the fresh embryo transfer following retrieval. If patients conceive a pregnancy, then investigators will follow the pregnancy through its resolution. Investigators will collect information about patients:
- pregnancy hormone levels,
- confirmation or pregnancy ultrasound findings,
- information on implantation, clinical pregnancy, miscarriage, and live births.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Ketorolac | Experimental | Drug: Ketorolac 30 mg IVParticipants randomized to this arm will receive 30mg IV Ketorolac at the conclusion of their oocyte retrieval. |
| No IV Ketorolac | No intervention | –Participants randomized to this arm will not receive IV Ketorolac at the conclusion of their oocyte retrieval. |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- IVF utilizing autologous oocytes and all sperm sources
- IVF cycles utilizing ICSI and standard insemination
- Plan to transfer embryo on day 5
- BMI below 50
Key exclusion criteria (1 listed)
- -allergies or medical contraindications to NSAIDs
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 |
|---|---|---|
| Ketorolac 30 mg IVWe will be evaluating the effect of post-oocyte retrieval ketorolac administration on clinical outcomes in fresh embryo transfer cycles. | Drug | IV Ketorolac |
Primary outcome
Implantation Rate
Time frame: From enrollment to the time of confirmation of pregnancy ultrasound at ~6 weeks post-oocyte retrieval (with or without administration of IV Ketorolac) .
Implantation rate following fresh embryo transfers in patients receiving ketorolac vs no ketorolac for post-retrieval analgesia. We define implantation rate as the proportion of transferred embryos which resulted in fetal heartbeat seen on ultrasound per patient.
4 secondary outcomes
Clinical Pregnancy Rate
Time frame: From enrollment to the time of confirmation of pregnancy ultrasound at ~6 weeks post-oocyte retrieval (with or without administration of IV Ketorolac) .
Miscarriage Rate
Time frame: From date of enrollment through first documented instance of miscarriage up to 40 weeks.
Live Birth Rate
Time frame: From enrollment to the end of pregnancy (~40 weeks) resulting from fresh embryo transfer following the oocyte retrieval in which patient received IV Ketorolac or no IV Ketorolac.
Post-operative Pain
Time frame: From enrollment until the time of discharge from oocyte retrieval (~2.5 hours).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Background: PubMed 23721715Mesen TB, Kacemi-Bourhim L, Marshburn PB, Usadi RS, Matthews M, Norton HJ, Hurst BS. The effect of ketorolac on pregnancy rates when used immediately after oocyte retrieval. Fertil Steril. 2013 Sep;100(3):725-8. doi: 10.1016/j.fertnstert.2013.04.048. Epub 2013 May 28.
- Background: PubMed 24572864Gobble RM, Hoang HLT, Kachniarz B, Orgill DP. Ketorolac does not increase perioperative bleeding: a meta-analysis of randomized controlled trials. Plast Reconstr Surg. 2014 Mar;133(3):741-755. doi: 10.1097/01.prs.0000438459.60474.b5.
- Background: PubMed 27429023Waljee JF, Li L, Brummett CM, Englesbe MJ. Iatrogenic Opioid Dependence in the United States: Are Surgeons the Gatekeepers? Ann Surg. 2017 Apr;265(4):728-730. doi: 10.1097/SLA.0000000000001904. No abstract available.
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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.
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 Ketorolac 30 mg IV in people with Infertility (IVF Patients) and Infertility Treatment, run by Jessica D. Kresowik 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 1 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: looking for participants now, as of the sponsor's last update on 15 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Kresowik, MD (563-355-2244, jessica-kresowik@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation Rate (time frame: From enrollment to the time of confirmation of pregnancy ultrasound at ~6 weeks post-oocyte retrieval (with or without administration of IV Ketorolac) .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07185724, which also lists 3 linked publications.
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 15 Dec 2025.