Ketorolac for Infertility Treatment

Overseen By Jessica Kresowik, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Jessica D. Kresowik

Must not be taking: NSAIDs

Disqualifiers: Allergies to NSAIDs, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether ketorolac, a pain medicine, affects outcomes for individuals undergoing IVF (in vitro fertilization) with fresh embryo transfers. Typically, ketorolac is avoided due to concerns about increased bleeding or reduced chances of successful embryo implantation in the uterus. The study will compare two groups: one receiving ketorolac after egg retrieval and one not receiving it, to assess any impact on implantation and live birth rates. Ideal participants are those planning a fresh embryo transfer on day 5 of their IVF cycle and without allergies to NSAIDs (a type of pain reliever). As a Phase 4 trial, this study involves an FDA-approved treatment, aiming to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for ketorolac?

Research has shown that using ketorolac, a pain reliever, after egg retrieval in IVF (in vitro fertilization) does not negatively affect pregnancy outcomes. Studies examining hundreds of cases have found that ketorolac does not reduce the chances of pregnancy. For instance, one study examined 454 patients and found no negative impact on IVF success when ketorolac was used after egg retrieval.

Ketorolac is commonly used for pain relief in IVF cycles where embryos are frozen, and it has not been linked to an increased risk of bleeding or a lower chance of pregnancy. Recent studies from Boston and Chapel Hill confirm that ketorolac effectively relieves pain and does not harm fresh embryo transfers.

Overall, available research suggests that ketorolac is safe and does not increase risks in IVF procedures. While some clinics remain cautious, current evidence reassures the safety of ketorolac in this context. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using Ketorolac for infertility treatment because of its unique anti-inflammatory properties. Unlike traditional infertility treatments that often focus on hormone regulation, Ketorolac, a nonsteroidal anti-inflammatory drug (NSAID), targets inflammation that may affect fertility. This approach could offer a new pathway for improving outcomes in patients undergoing procedures like oocyte retrieval. Additionally, the delivery method of IV Ketorolac at the conclusion of oocyte retrieval is an innovative approach that may enhance its effectiveness in this setting.

What evidence suggests that ketorolac might be an effective treatment for infertility?

This trial will compare the use of IV Ketorolac with no intervention following oocyte retrieval. Studies have shown that ketorolac after egg retrieval in IVF does not harm pregnancy chances. Research indicates that ketorolac provides pain relief without lowering pregnancy rates and can reduce the need for stronger pain medications. Recent studies from Boston and Chapel Hill confirmed that ketorolac effectively controls pain without affecting the success of fresh embryo transfers. Although some clinics still avoid it due to past concerns, current evidence suggests ketorolac is safe and effective for use in IVF cycles. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals undergoing in vitro fertilization (IVF) who are planning a fresh embryo transfer. Participants must be suitable for IVF and prepared to have an embryo transferred within the same cycle as egg retrieval.

Inclusion Criteria

IVF utilizing autologous oocytes and all sperm sources

BMI below 50

Plan to transfer embryo on day 5

Exclusion Criteria

I am allergic or cannot take NSAIDs due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Oocyte Retrieval and Immediate Post-operative

Participants undergo oocyte retrieval and receive either ketorolac or no ketorolac for post-retrieval analgesia while still under sedation

1 day

1 visit (in-person)

Embryo Transfer

Embryo transfer is performed 5 days post-retrieval

5 days post-retrieval

1 visit (in-person)

Follow-up

Participants are monitored for implantation, clinical pregnancy, miscarriage, and live birth rates

45 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ketorolac

Trial Overview The study tests if Ketorolac, a pain reliever given through IV after egg retrieval, affects implantation and live birth rates in IVF. It's a double-blind randomized controlled trial where half of the participants will receive Ketorolac while the other half won't.

How Is the Trial Designed?

Group I: IV Ketorolac Experimental Treatment 1 Intervention

Participants randomized to this arm will receive 30mg IV Ketorolac at the conclusion of their oocyte retrieval.

Group II: No IV Ketorolac Active Control 1 Intervention

Participants randomized to this arm will not receive IV Ketorolac at the conclusion of their oocyte retrieval.

Who Is Running the Clinical Trial?

Jessica D. Kresowik

Lead Sponsor

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23721715/

The effect of ketorolac on pregnancy rates when used ... Conclusion(s): This study suggests ketorolac has no apparent detrimental effect on IVF pregnancy outcomes when administered immediately after oocyte retrieval.

2. fertstert.org fertstert.org/article/S0015-0282(13)00562-1/fulltext

The effect of ketorolac on pregnancy rates when used ... Conclusion(s). This study suggests ketorolac has no apparent detrimental effect on IVF pregnancy outcomes when administered immediately after oocyte retrieval.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07185724

Ketorolac Use and Fresh Embryo Transfer Outcomes Primary outcome will be implantation rate following fresh embryo transfers in patients receiving ketorolac (30mg IV) vs no ketorolac for post-retrieval ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666334121000076

Routine ketorolac at oocyte retrieval decreases ... In the KG, we found a significant decrease in the patients who required narcotics after oocyte retrieval compared with the NKG (12% KG vs. 25.5% NKG).

5. fertstertreports.org fertstertreports.org/article/S2666-3341(21)00027-1/fulltext

Ketorolac use after oocyte retrieval: doing our part to ... This study offers critical insights on the basis of a large cohort and considers all of the competing interests at stake that have, to this ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8267402/

Routine ketorolac at oocyte retrieval decreases ... (14) retrospectively reviewed 454 patients and found no apparent deleterious effects on IVF pregnancy outcomes when ketorolac was given after oocyte retrieval.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0015028213005621

The effect of ketorolac on pregnancy rates when used ... Conclusion(s). This study suggests ketorolac has no apparent detrimental effect on IVF pregnancy outcomes when administered immediately after oocyte retrieval.