Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07185724

Ketorolac Use and Fresh Embryo Transfer Outcomes

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

UI Health Care Center for Advanced Reproductive Care

Iowa City, Iowa, 52245, United States

Location status: Recruiting

Location contact

Abey Eapen

SUB_INVESTIGATOR

Abigail Mancuso

SUB_INVESTIGATOR

Aya Iwamoto

SUB_INVESTIGATOR

Aya Iwamoto, MD

CONTACT

[email protected]

(319) 356-1767

Hakan Duran

SUB_INVESTIGATOR

Jessica Kresowik

PRINCIPAL_INVESTIGATOR

Melissa Mathes

SUB_INVESTIGATOR

Salomeh Salari

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

-allergies or medical contraindications to NSAIDs

Treatment and study plan

Ketorolac 30 mg IV

Drug

We will be evaluating the effect of post-oocyte retrieval ketorolac administration on clinical outcomes in fresh embryo transfer cycles.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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) .

    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.

  2. Miscarriage Rate

    Time frame: From date of enrollment through first documented instance of miscarriage up to 40 weeks.

    Miscarriage rate is defined as the percentage of patients with miscarriage after a clinical pregnancy.

  3. 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.

    Live birth rate is defined as percentage of patients who had a transfer which resulted in a live birth.

  4. Post-operative Pain

    Time frame: From enrollment until the time of discharge from oocyte retrieval (~2.5 hours).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Kresowik, MD

CONTACT

[email protected]

563-355-2244

Sponsors and collaborators

Lead sponsor

Jessica D. Kresowik

Other

Registry information

Official study title

Balancing Comfort and Success: Post-retrieval Ketorolac in Fresh Embryo Transfers

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 22, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.