Balancing Comfort and Success: Post-retrieval Ketorolac in Fresh Embryo Transfers
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Implantation Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participant, investigator, IVF provider, nursing team, and all members involved in assessing outcomes will be blinded. Patient will be under anesthetic influence and be unaware of medication administration. Recovery nurse and surgeon will not be aware or informed of treatment arm.
Anesthesia will be unblinded but will not inform any other members of the medical team whether or not patient received ketorolac.
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •allergies or medical contraindications to NSAIDs
研究组 & 干预措施
IV Ketorolac
Participants randomized to this arm will receive 30mg IV Ketorolac at the conclusion of their oocyte retrieval.
干预措施: Ketorolac 30 mg IV (Drug)
结局指标
主要结局
Implantation Rate
时间窗: 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.
次要结局
- Clinical Pregnancy Rate(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(From date of enrollment through first documented instance of miscarriage up to 40 weeks.)
- Live Birth Rate(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(From enrollment until the time of discharge from oocyte retrieval (~2.5 hours).)
研究者
Jessica D. Kresowik
Clinical Associate Professor
University of Iowa