Recruiting
Phase 1

Ketorolac

Sponsor:

Shady Grove Fertility Reproductive Science Center

Code:

NCT06026553

Conditions

Infertility

Infertility, Female

Oocyte Retrieval

Postoperative Pain

Embryo Transfer

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Ketorolac (Toradol)

Placebo (saline)

Study Details

Brief summary:

To determine if a nonsteroidal anti-inflammatory drug (NSAID), Ketorolac (Toradol), can improve pain control and decrease narcotic use after undergoing egg retrieval.

Conditions

Infertility

Infertility, Female

Oocyte Retrieval

Postoperative Pain

Embryo Transfer

Study ID

NCT06026553

Start date

Aug 10, 2022

Status verified date

Aug, 2023

Completion date

Jan, 2025

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Signed informed consent
2. Females over 18 years of age who are scheduled to undergo oocyte retrieval
3. Patients must be able to read and understand written English or have an appropriate certified medical translator available.
4. Standard eligibility criteria to undergo IVF and embryo transfer at Shady Grove

Exclusion Criteria:

1. Known allergy to ketorolac
2. Those with known medical conditions precluding them from ketorolac use (active peptic ulcer disease, recent or history of hemorrhage or perforation, known renal or hepatic insufficiency, suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, bleeding disorders, recent myocardial infarction, or stroke.)
3. BMI ≥ 40 kg/m2
4. History of substance abuse
5. Chronic opioid use
6. Transabdominal oocyte retrieval

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Standard post-operative pain management + 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. 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.

placebo comparator: Standard post-operative pain management + Placebo (saline)

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.

Interventions

Ketorolac (Toradol)

IV Ketorolac (Toradol) will be administered at conclusion of oocyte retrieval. All enrolled patients will receive standard post-operative pain management.

Placebo (saline)

IV Placebo (saline) will be administered at conclusion of oocyte retrieval. All enrolled patients will receive standard post-operative pain management.

Primary outcome measure

  • Administration of IV narcotic for rescue analgesia during recovery in the post anesthesia care unit (PACU) [ Time Frame: Oocyte retrieval procedure day ]

Central Contacts and Locations

Central contacts

Tasha Newsome

(301)545-1289tasha.newsome@sgfertility.com

Locations

Shady Grove Fertility Reproductive Science Center

Recruiting

Rockville, Maryland, United States, 20850

Contacts

Tasha Newsome

301-545-1289tasha.newsome@sgfertility.com

Principal Investigator:

Kathleen Devine, MD

Shady Grove Fertility Reproductive Science Center

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Tasha Newsome

301-545-1289tasha.newsome@sgfertility.com

More Information

Sponsor

Shady Grove Fertility Reproductive Science Center

Last update posted

Sep 7, 2023

Last verified

Aug, 2023

Keywords

  • Infertility, Female
  • In Vitro Fertilization
  • IVF
  • Oocyte Retrieval
  • Postoperative Pain Control
  • NSAID
  • Ketorolac
  • Non-Narcotic Analgesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Shady Grove Fertility Reproductive Science Center on 2023-09-07.