InfertilityPhase 1AlleviateNCT06026553
Assessing Ketorolac (Toradol) at Oocyte Retrieval
A Phase 1 study testing Ketorolac (Toradol) in people with Infertility and Infertility, Female, run by Shady Grove Fertility Reproductive Science Center at 2 sites in United States.
Trial summary
To determine if a nonsteroidal anti-inflammatory drug (NSAID), Ketorolac (Toradol), can improve pain control and decrease narcotic use after undergoing egg retrieval. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility, Infertility, Female, Oocyte Retrieval
- What is being tested?
- Ketorolac (Toradol)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Aug 2022to Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent
- Females over 18 years of age who are scheduled to undergo oocyte retrieval
- Patients must be able to read and understand written English or have an appropriate certified medical translator available.
- Standard eligibility criteria to undergo IVF and embryo transfer at Shady Grove
Who cannot join
- Known allergy to ketorolac
- 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.)
- BMI ≥ 40 kg/m2
- History of substance abuse
- Chronic opioid use
- Transabdominal oocyte retrieval
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Shady Grove Fertility Reproductive Science Center
Fairfax, Virginia, 22031
Tasha Newsome, 301-545-1289, tasha.newsome@sgfertility.com
- Recruiting
Shady Grove Fertility Reproductive Science Center
Rockville, Maryland, 20850
Tasha Newsome, 301-545-1289, tasha.newsome@sgfertility.com
Kathleen Devine, MD
About this study
Official title: A Randomized Blinded Placebo Controlled Trial Assessing Ketorolac (Toradol) at Oocyte Retrieval
To determine if a nonsteroidal anti-inflammatory drug (NSAID), Ketorolac (Toradol), can improve pain control and decrease narcotic use after undergoing egg retrieval.
Read the detailed description
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.
- Being tested
- Ketorolac (Toradol), Placebo (saline)
- Keywords
- Infertility, Female, In Vitro Fertilization, IVF, Oocyte Retrieval, Postoperative Pain Control, NSAID, Ketorolac, Non-Narcotic Analgesia
- Medical subject headings
- Infertility, Infertility, Female, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac (Toradol)Drug
IV Ketorolac (Toradol) will be administered at conclusion of oocyte retrieval. All enrolled patients will receive standard post-operative pain management.
Placebo (saline)Other
IV Placebo (saline) will be administered at conclusion of oocyte retrieval. All enrolled patients will receive standard post-operative pain management.
| Study group | Role | What they receive |
|---|---|---|
| Standard post-operative pain management + Ketorolac (Toradol) | Experimental | 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. Receives: Drug: Ketorolac (Toradol) |
| Standard post-operative pain management + Placebo (saline) | Placebo comparator | 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. Receives: Other: Placebo (saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Oocyte retrieval procedure day
Secondary outcomes (13)
Dose of narcotic for rescue analgesia during recovery in the PACU
Dose of narcotic administered for rescue analgesia during recovery in the PACU
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start10 Aug 2022
- Primary completionDec 2023 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shady Grove Fertility Reproductive Science Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen Devine, MD, Principal investigator, Shady Grove Fertility Reproductive Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026553
- Sponsor's protocol ID
- TORA-IVF-01
- Acronym
- Alleviate
- Status last verified
- Aug 2023
- First submitted
- 22 Aug 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Waljee JF, Li L, Brummett CM, Englesbe MJ. Iatrogenic Opioid Dependence in the United States: Are Surgeons the Gatekeepers? Ann Surg. 2017 Apr;265(4):728-730. doi: 10.1097/SLA.0000000000001904. No abstract available.
PubMed 27429023Centers for Disease Control and Prevention. 2017 Assisted Reproductive Technology National Summary Report. US Dept of Health and Human Services; 2021.
Wilson N, Kariisa M, Seth P, Smith H 4th, Davis NL. Drug and Opioid-Involved Overdose Deaths - United States, 2017-2018. MMWR Morb Mortal Wkly Rep. 2020 Mar 20;69(11):290-297. doi: 10.15585/mmwr.mm6911a4.
PubMed 32191688Kiani Z, Simbar M, Hajian S, Zayeri F. The prevalence of depression symptoms among infertile women: a systematic review and meta-analysis. Fertil Res Pract. 2021 Mar 4;7(1):6. doi: 10.1186/s40738-021-00098-3.
PubMed 33663615Kato T, Sampei M, Saito K, Morisaki N, Urayama KY. Depressive symptoms, anxiety, and quality of life of Japanese women at initiation of ART treatment. Sci Rep. 2021 Apr 6;11(1):7538. doi: 10.1038/s41598-021-87057-6.
PubMed 33824373Walter JR. Ketorolac use after oocyte retrieval: doing our part to combat the opioid crisis. F S Rep. 2021 Mar 12;2(2):142-143. doi: 10.1016/j.xfre.2021.03.001. eCollection 2021 Jun. No abstract available.
PubMed 34278342Brown CR, Moodie JE, Wild VM, Bynum LJ. Comparison of intravenous ketorolac tromethamine and morphine sulfate in the treatment of postoperative pain. Pharmacotherapy. 1990;10(6 ( Pt 2)):116S-121S.
PubMed 2082307Gobble RM, Hoang HLT, Kachniarz B, Orgill DP. Ketorolac does not increase perioperative bleeding: a meta-analysis of randomized controlled trials. Plast Reconstr Surg. 2014 Mar;133(3):741-755. doi: 10.1097/01.prs.0000438459.60474.b5.
PubMed 24572864Greer IA. Effects of ketorolac tromethamine on hemostasis. Pharmacotherapy. 1990;10(6 ( Pt 2)):71S-76S.
PubMed 2082316Maslin B, Lipana L, Roth B, Kodumudi G, Vadivelu N. Safety Considerations in the Use of Ketorolac for Postoperative Pain. Curr Drug Saf. 2017;12(1):67-73. doi: 10.2174/1574886311666160719154420.
PubMed 27440142Kang J, Chapdelaine P, Laberge PY, Fortier MA. Functional characterization of prostaglandin transporter and terminal prostaglandin synthases during decidualization of human endometrial stromal cells. Hum Reprod. 2006 Mar;21(3):592-9. doi: 10.1093/humrep/dei400. Epub 2005 Dec 8.
PubMed 16339169Mesen TB, Kacemi-Bourhim L, Marshburn PB, Usadi RS, Matthews M, Norton HJ, Hurst BS. The effect of ketorolac on pregnancy rates when used immediately after oocyte retrieval. Fertil Steril. 2013 Sep;100(3):725-8. doi: 10.1016/j.fertnstert.2013.04.048. Epub 2013 May 28.
PubMed 23721715Seidler EA, Vaughan DA, Leung AQ, Sakkas D, Ryley DA, Penzias AS. Routine ketorolac at oocyte retrieval decreases postoperative narcotic use by more than 50. F S Rep. 2021 Feb 10;2(2):156-160. doi: 10.1016/j.xfre.2021.02.003. eCollection 2021 Jun.
PubMed 34278347Siristatidis CS, Basios G, Pergialiotis V, Vogiatzi P. Aspirin for in vitro fertilisation. Cochrane Database Syst Rev. 2016 Nov 3;11(11):CD004832. doi: 10.1002/14651858.CD004832.pub4.
PubMed 27807847
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Blinded Placebo Controlled Trial Assessing Ketorolac (Toradol) at Oocyte Retrieval
- ClinicalTrials.gov ID
- NCT06026553
- Acronym / sponsor ID
- Alleviate / TORA-IVF-01
- Keywords
- Infertility, Female, In Vitro Fertilization, IVF, Oocyte Retrieval, Postoperative Pain Control, NSAID, Ketorolac, Non-Narcotic Analgesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shady Grove Fertility Reproductive Science CenterUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if a nonsteroidal anti-inflammatory drug (NSAID), Ketorolac (Toradol), can improve pain control and decrease narcotic use after undergoing egg retrieval.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard post-operative pain management + Ketorolac (Toradol) | Experimental | 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. 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. |
| Standard post-operative pain management + Placebo (saline) | Placebo comparator | Other: 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Females over 18 years of age who are scheduled to undergo oocyte retrieval
- Patients must be able to read and understand written English or have an appropriate certified medical translator available.
- Standard eligibility criteria to undergo IVF and embryo transfer at Shady Grove
Key exclusion criteria (6 listed)
- Known allergy to ketorolac
- 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.)
- BMI ≥ 40 kg/m2
- History of substance abuse
- Chronic opioid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketorolac (Toradol)IV Ketorolac (Toradol) will be administered at conclusion of oocyte retrieval. All enrolled patients will receive standard post-operative pain management. | Drug | Standard post-operative pain management + Ketorolac (Toradol) |
| Placebo (saline)IV Placebo (saline) will be administered at conclusion of oocyte retrieval. All enrolled patients will receive standard post-operative pain management. | Other | Standard post-operative pain management + Placebo (saline) |
Primary outcome
Administration of IV narcotic for rescue analgesia during recovery in the post anesthesia care unit (PACU)
Time frame: Oocyte retrieval procedure day
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).
13 secondary outcomes
Dose of narcotic 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
Time frame: Oocyte retrieval procedure day
Intensity of pain at baseline
Time frame: Oocyte retrieval procedure day
Intensity of pain in PACU
Time frame: Oocyte retrieval procedure day
Intensity of pain after discharge
Time frame: From oocyte retrieval procedure day up to 1 week post oocyte retrieval
Home narcotic use
Time frame: From oocyte retrieval procedure day up to 1 week post oocyte retrieval
Incidence of complications and adverse events
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.
Time frame: From date of randomization until ~10 days following embryo transfer
Clinical pregnancy rate for patients who proceed to a fresh embryo transfer.
Time frame: From date of randomization until 5-8 weeks estimated gestational age
Implantation rate for patients who proceed to a fresh embryo transfer.
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.
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.
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Background: PubMed 27429023Waljee JF, Li L, Brummett CM, Englesbe MJ. Iatrogenic Opioid Dependence in the United States: Are Surgeons the Gatekeepers? Ann Surg. 2017 Apr;265(4):728-730. doi: 10.1097/SLA.0000000000001904. No abstract available.
- BackgroundCenters for Disease Control and Prevention. 2017 Assisted Reproductive Technology National Summary Report. US Dept of Health and Human Services; 2021.
- Background: PubMed 32191688Wilson N, Kariisa M, Seth P, Smith H 4th, Davis NL. Drug and Opioid-Involved Overdose Deaths - United States, 2017-2018. MMWR Morb Mortal Wkly Rep. 2020 Mar 20;69(11):290-297. doi: 10.15585/mmwr.mm6911a4.
- Background: PubMed 33663615Kiani Z, Simbar M, Hajian S, Zayeri F. The prevalence of depression symptoms among infertile women: a systematic review and meta-analysis. Fertil Res Pract. 2021 Mar 4;7(1):6. doi: 10.1186/s40738-021-00098-3.
- Background: PubMed 33824373Kato T, Sampei M, Saito K, Morisaki N, Urayama KY. Depressive symptoms, anxiety, and quality of life of Japanese women at initiation of ART treatment. Sci Rep. 2021 Apr 6;11(1):7538. doi: 10.1038/s41598-021-87057-6.
- Background: PubMed 34278342Walter JR. Ketorolac use after oocyte retrieval: doing our part to combat the opioid crisis. F S Rep. 2021 Mar 12;2(2):142-143. doi: 10.1016/j.xfre.2021.03.001. eCollection 2021 Jun. No abstract available.
- Background: PubMed 2082307Brown CR, Moodie JE, Wild VM, Bynum LJ. Comparison of intravenous ketorolac tromethamine and morphine sulfate in the treatment of postoperative pain. Pharmacotherapy. 1990;10(6 ( Pt 2)):116S-121S.
- Background: PubMed 24572864Gobble RM, Hoang HLT, Kachniarz B, Orgill DP. Ketorolac does not increase perioperative bleeding: a meta-analysis of randomized controlled trials. Plast Reconstr Surg. 2014 Mar;133(3):741-755. doi: 10.1097/01.prs.0000438459.60474.b5.
- Background: PubMed 2082316Greer IA. Effects of ketorolac tromethamine on hemostasis. Pharmacotherapy. 1990;10(6 ( Pt 2)):71S-76S.
- Background: PubMed 27440142Maslin B, Lipana L, Roth B, Kodumudi G, Vadivelu N. Safety Considerations in the Use of Ketorolac for Postoperative Pain. Curr Drug Saf. 2017;12(1):67-73. doi: 10.2174/1574886311666160719154420.
- Background: PubMed 16339169Kang J, Chapdelaine P, Laberge PY, Fortier MA. Functional characterization of prostaglandin transporter and terminal prostaglandin synthases during decidualization of human endometrial stromal cells. Hum Reprod. 2006 Mar;21(3):592-9. doi: 10.1093/humrep/dei400. Epub 2005 Dec 8.
- Background: PubMed 23721715Mesen TB, Kacemi-Bourhim L, Marshburn PB, Usadi RS, Matthews M, Norton HJ, Hurst BS. The effect of ketorolac on pregnancy rates when used immediately after oocyte retrieval. Fertil Steril. 2013 Sep;100(3):725-8. doi: 10.1016/j.fertnstert.2013.04.048. Epub 2013 May 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Devine, MD principal investigator
Shady Grove Fertility Reproductive Science Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketorolac (Toradol) in people with Infertility and Infertility, Female, run by Shady Grove Fertility Reproductive Science Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tasha Newsome ((301)545-1289, tasha.newsome@sgfertility.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06026553, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.