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Current standard of care is no pretreatment medications before the egg retrieval, and the investigators would like to evaluate if preoperative Tylenol improves procedure and post procedure pain control over the current practice (no pre-treatment). Specifically, this study will compare Tylenol with a placebo when given before retrieval procedures. The investigators believe that if Tylenol can offer better analgesic relief than no pretreatment medications, then it may reduce the amount of narcotics needed by patients during and after the procedure and contribute to better patient satisfaction. . This study will enroll 100 participants all from University of Alabama at Birmingham (UAB).
The current standard of care for oocyte retrieval in IVF involves fentanyl, propofol, as well as oxycodone. However, there exists little data of alternatives to narcotic medications for analgesic purposes in oocyte retrieval procedures. A retrospective study published in 2013 showed potential for NSAID's, specifically ketorolac, to significantly improve pain scores in women undergoing oocyte retrieval. It was also shown that the use of these medications did not significantly alter pregnancy rate, live birth rate, or miscarriage rate in these patients. Few other studies have delved into the question of anesthetics for oocyte retrievals except a prospective study in 2006. This study shows that no significant difference in pregnancy rates of implantation occurs with the use of acetaminophen and diclofenac vs. acetaminophen alone if given post-operatively. However, pain was not measured in this study for either group. Therefore, it is clear that there exists limited data on the subject of analgesics used in oocyte retrievals for in vitro fertilization and that more exploration into alternative medications is required to find the most effective and least harmful option.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Control group participants will receive unlabelled 2 non-active placebo tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. |
|
| Experimental | Experimental | Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | Acetaminophen total dose of 1000mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median of Cumulative Pain Scores Up to 60 Minutes Post Procedure | Median of cumulative pain scores (measured on a visual analog scale from 0-10 where 0=no pain and 10=worst pain) taken during the recovery period (15, 30, 45, and 60 minutes post procedure) | 60 minutes post-procedure |
| Median of Cumulative Pain Scores Up to 24 Hours Post Procedure | Median Pain score (measured on a visual analog scale from 0-10 where 0=no pain and 10=worst pain) taken at 24-hours post-procedure | 24-hours post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Use of Analgesics up to 60 Minutes Post Procedure | Number of participants requiring use of analgesic medications in the post-operative recovery suite | 60-minutes post-procedure |
| Number of Participants With Use of Analgesics in the First 24 Hours After Discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deidre D Gunn, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deidre D Gunn, MD | Birmingham | Alabama | 35233 | United States |
Study Protocol and Statistical Analysis Plan
To Be Determined
Shared through CT.gov
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Control group participants will receive unlabelled 2 non-active placebo tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. placebo: subjects randomized to this group will be given placebo tablets |
| FG001 | Experimental | Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. Acetaminophen: Acetaminophen total dose of 1000mg |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Of 99 patients enrolled, 72 required re-consent. Of these, 39 re-consented and 33 could not be re-consented. Therefore, these 33 were excluded, leaving 66 patients for analysis. Two of these were lost to follow-up and were excluded, leaving 64 women (31 control, 33 active arm) in the final analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Control group participants will receive unlabelled 2 non-active placebo tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. placebo: subjects randomized to this group will be given placebo tablets |
| BG001 | Experimental |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Median of Cumulative Pain Scores Up to 60 Minutes Post Procedure | Median of cumulative pain scores (measured on a visual analog scale from 0-10 where 0=no pain and 10=worst pain) taken during the recovery period (15, 30, 45, and 60 minutes post procedure) | Of 99 patients enrolled, 72 required re-consent. Of these, 39 re-consented and 33 could not be re-consented. Therefore, these 33 were excluded, leaving 66 patients for analysis. Two of these were lost to follow-up and were excluded, leaving 64 women (31 control, 33 active arm) in the final analysis. | Posted | Median | Inter-Quartile Range | score on a scale | 60 minutes post-procedure |
|
Each participant was measured from baseline through 24 hours post-procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Control group participants will receive unlabelled 2 non-active placebo tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. placebo: subjects randomized to this group will be given placebo tablets |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deidre Gunn, Assistant Professor | University of Alabama at Birmingham | 205-934-1030 | ddowns@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 19, 2018 | Dec 20, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| placebo | Drug | subjects randomized to this group will be given placebo tablets |
|
|
Number of participants with use of analgesic medications in the first 24 hours after discharge from procedure |
| 60-minutes post-procedure to 24-hours after procedure |
Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. Acetaminophen: Acetaminophen total dose of 1000mg |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Experimental | Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. Acetaminophen: Acetaminophen total dose of 1000mg |
|
|
| Primary | Median of Cumulative Pain Scores Up to 24 Hours Post Procedure | Median Pain score (measured on a visual analog scale from 0-10 where 0=no pain and 10=worst pain) taken at 24-hours post-procedure | Of 99 patients enrolled, 72 required re-consent. Of these, 39 re-consented and 33 could not be re-consented. Therefore, these 33 were excluded, leaving 66 patients for analysis. Two of these were lost to follow-up and were excluded, leaving 64 women (31 control, 33 active arm) in the final analysis. | Posted | Median | Inter-Quartile Range | score on a scale | 24-hours post-procedure |
|
|
|
| Secondary | Number of Participants With Use of Analgesics up to 60 Minutes Post Procedure | Number of participants requiring use of analgesic medications in the post-operative recovery suite | Of 99 patients enrolled, 72 required re-consent. Of these, 39 re-consented and 33 could not be re-consented. Therefore, these 33 were excluded, leaving 66 patients for analysis. Two of these were lost to follow-up and were excluded, leaving 64 women (31 control, 33 active arm) in the final analysis. | Posted | Count of Participants | Participants | 60-minutes post-procedure |
|
|
|
| Secondary | Number of Participants With Use of Analgesics in the First 24 Hours After Discharge | Number of participants with use of analgesic medications in the first 24 hours after discharge from procedure | Of 99 patients enrolled, 72 required re-consent. Of these, 39 re-consented and 33 could not be re-consented. Therefore, these 33 were excluded, leaving 66 patients for analysis. Two of these were lost to follow-up and were excluded, leaving 64 women (31 control, 33 active arm) in the final analysis. | Posted | Count of Participants | Participants | 60-minutes post-procedure to 24-hours after procedure |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 4 |
| 31 |
| EG001 | Experimental | Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. Acetaminophen: Acetaminophen total dose of 1000mg | 0 | 33 | 0 | 33 | 9 | 33 |
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D002241 | Carbohydrates |