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.
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
None
Parallel
Ketorolac 30 mg IV
DrugWe will be evaluating the effect of post-oocyte retrieval ketorolac administration on clinical outcomes in fresh embryo transfer cycles.
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.
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.
Miscarriage Rate
Miscarriage rate is defined as the percentage of patients with miscarriage after a clinical pregnancy.
Live Birth Rate
Live birth rate is defined as percentage of patients who had a transfer which resulted in a live birth.
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.
Click on the lead sponsor to view all of their trials.
Jessica D. Kresowik
Lead sponsor
University of Iowa
Sponsor institution
