A Phase 1 interventional study of Ketorolac (Toradol) and Placebo (saline) in Infertility, Infertility, Female and Oocyte Retrieval, sponsored by Shady Grove Fertility Reproductive Science Center. Recruiting at 2 sites in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-09-07.
Sponsored by Shady Grove Fertility Reproductive Science Center · Phase 1, Interventional, and Supportive care
To determine if a nonsteroidal anti-inflammatory drug (NSAID), Ketorolac (Toradol), can improve pain control and decrease narcotic use after undergoing egg retrieval.
Postoperative pain control is an essential component to any surgical procedure. Surgery represents a time during which opioid-naïve patients may be exposed to narcotics, risking opioid related complications and future opioid-use disorder. Approximately 150,000 oocyte retrievals are performed per year in the United States, according to the 2017 Assisted Reproductive Technology National Summary Report. A reduction in exposure to narcotics in this field has significant public health implications, particularly given that approximately 6% of new persistent opioid use occurs following minor surgical procedures.
Ketorolac (Toradol) has been demonstrated to be a safe and efficacious agent to achieve pain control postoperatively with no significant increase in adverse events.
The purpose of this prospective randomized blinded placebo controlled trial is to determine if a nonsteroidal anti-inflammatory drug (NSAID), Ketorolac (Toradol), can improve pain control and decrease narcotic use after undergoing egg retrieval.
Approximately 400 women (n=200 in each arm) will be enrolled according to the inclusion/exclusion criteria among patients of Shady Grove Fertility. Participants will undergo a standard in vitro fertilization cycle (IVF) followed by egg retrieval (ER). Participants will be randomized to receive either IV ketorolac or IV placebo at the conclusion of the egg retrieval, administered by the anesthesia provider. All enrolled patients will receive standard post-operative pain management. The investigational component of this study lies in assessing post-operative pain control in the immediate post-operative period and in the post-operative period after discharge as reflected by pain scores and narcotic medication usage.
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This study's planned enrollment of 400 is above the median of 120 across 1,698 interventional studies indexed under Infertility.
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Exclusion Criteria:
Subject will undergo an IVF cycle with ovarian hyperstimulation and oocyte retrieval. Standard protocols will be used for both study groups and involve administration of gonadotropins to stimulate ovarian follicle growth and regular monitoring with ultrasound and serum estradiol and progesterone levels until follicles reach a desired size. Human Chorionic Gonadotropin (HCG) or leuprolide acetate will be administered to trigger final oocyte maturation prior to oocyte retrieval under anesthesia. On the day of oocyte retrieval, the anesthesia provider will provide syringes of IV ketorolac (30 mg if ≥50 kg or 15 mg if \<50 kg per manufacturer dosing) or IV placebo (saline). If assigned to the study arm, IV ketorolac will be administered by the anesthesia provider. All enrolled patients will receive standard post-operative pain management. Patients will be contacted post-operatively, to access pain scores and record the amount of the prescribed narcotic medications utilized since discharge.
Drug: Ketorolac (Toradol)
Subject will undergo an IVF cycle with ovarian hyperstimulation and oocyte retrieval. Standard protocols will be used for both study groups and involve administration of gonadotropins to stimulate ovarian follicle growth and regular monitoring with ultrasound and serum estradiol and progesterone levels until follicles reach a desired size. HCG or leuprolide acetate will be administered to trigger final oocyte maturation prior to oocyte retrieval under anesthesia. On the day of oocyte retrieval, the anesthesia provider will provide syringes of IV ketorolac (30 mg if ≥50 kg or 15 mg if \<50 kg per manufacturer dosing) or IV placebo (saline). If assigned to the control arm, IV placebo (saline) will be administered by the anesthesia provider. All enrolled patients will receive standard post-operative pain management. Patients will be contacted post-operatively, to access pain scores and record the amount of the prescribed narcotic medications utilized since discharge.
Other: Placebo (saline)
IV Ketorolac (Toradol) will be administered at conclusion of oocyte retrieval. All enrolled patients will receive standard post-operative pain management.
IV Placebo (saline) will be administered at conclusion of oocyte retrieval. All enrolled patients will receive standard post-operative pain management.
Administration of IV narcotic for rescue analgesia during recovery in the post anesthesia care unit (PACU)
The primary objective is to evaluate the use of ketorolac as a safe and effective analgesic after transvaginal oocyte retrieval (TVOR) by assessing the number of patients requiring additional analgesia with IV narcotic during recovery in the post anesthesia care unit (PACU).
Time frame: Oocyte retrieval procedure day
Dose of narcotic for rescue analgesia during recovery in the PACU
Dose of narcotic administered for rescue analgesia during recovery in the PACU
Time frame: Oocyte retrieval procedure day
Type of narcotic for rescue analgesia during recovery in the PACU
Type of narcotic administered for rescue analgesia during recovery in the PACU
Time frame: Oocyte retrieval procedure day
Intensity of pain at baseline
Pain (measured on a scale of 0 (no pain) to 10 (worst pain imaginable)): baseline pain score
Time frame: Oocyte retrieval procedure day
Intensity of pain in PACU
Pain (measured on a scale of 0 (no pain) to 10 (worst pain imaginable)): PACU pain scores (scored 0-10)
Time frame: Oocyte retrieval procedure day
Intensity of pain after discharge
Pain (measured on a scale of 0 (no pain) to 10 (worst pain imaginable)): Home pain scores (scored 0-10)
Time frame: From oocyte retrieval procedure day up to 1 week post oocyte retrieval
Home narcotic use
Home post-operative narcotic use (recorded as number of pills)
Time frame: From oocyte retrieval procedure day up to 1 week post oocyte retrieval
Incidence of complications and adverse events
Data will be collected on the oocyte retrieval procedure including complications and adverse events in the intra-operative and post-operative periods
Time frame: From oocyte retrieval procedure day up to 1 week post oocyte retrieval
Biochemical pregnancy rate for patients who proceed to a fresh embryo transfer.
Biochemical pregnancy is defined as the detection of beta HCG above 5 IU/L
Time frame: From date of randomization until ~10 days following embryo transfer
Clinical pregnancy rate for patients who proceed to a fresh embryo transfer.
Clinical pregnancy is defined as the presence of a gestational sac(s)
Time frame: From date of randomization until 5-8 weeks estimated gestational age
Implantation rate for patients who proceed to a fresh embryo transfer.
Implantation rate is defined as the maximum number of gestational sacs per patient
Time frame: From date of randomization until 7-8 weeks estimated gestational age
Ongoing implantation rate for patients who proceed to a fresh embryo transfer.
The ongoing implantation rate is defined as maximum number of fetal heartbeats divided by total number of embryos transferred
Time frame: From date of randomization until 7-8 weeks estimated gestational age
Pregnancy loss rate for patients who proceed to a fresh embryo transfer.
Miscarriage; either biochemical or clinical pregnancy loss. Biochemical pregnancy loss is defined as initial positive beta HCG that did not progress to clinical pregnancy. Clinical pregnancy loss is defined as clinical pregnancy not progressing to live birth. Total pregnancy loss is defined as biochemical and clinical pregnancy loss (initial positive beta HCG that did not progress to live birth).
Time frame: From date of randomization until pregnancy loss, assessed up to 11 months
Live birth rate for patients who proceed to a fresh embryo transfer.
Live birth is defined as birth of a liveborn infant at an estimated gestational age of at least 23 weeks or greater.
Time frame: From date of randomization until live born infant at an estimated gestational age of at least 23 weeks or greater, assessed up to 11 months
Plan to share: No
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