Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction
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ClinicalTrials.gov Identifier: NCT03105518 |
Recruitment Status :
Active, not recruiting
First Posted : April 10, 2017
Results First Posted : December 5, 2017
Last Update Posted : August 3, 2022
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Condition or disease | Intervention/treatment | Phase |
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Oocyte Retrieval Postoperative Pain | Drug: Fentanyl Drug: Acetaminophen Drug: Oxycodone | Phase 4 |
Subject will undergo standard clinical protocols for the entire oocyte stimulation cycle and all assisted reproductive procedure decisions and algorithms will be decided entirely independent of this study.
The anesthetic and postoperative pain regimens will use the same agents and dose ranges used in clinical standard practice; however, the regimens will be standardized, so as to limit confounding variables. The study regimen for anesthesia will differ from the current, clinical standard by the mandated use of actual body weight (in current practice, actual, adjusted ideal, or ideal body weights are used), the use of fentanyl 1 mcg/kg IV (instead of 100 mcg for everyone), and the standardization of postoperative analgesia (noted below). The total amount of fentanyl, propofol, and postoperative drugs will be recorded.
Postoperative analgesia will be standardized based on the subject's self reported verbal analogue score (VAS) and the timing of the report. The agents and timing used below differ from the current clinical standard by assessing VAS and responding with a certain regimen.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Assessment of immediate and delayed postoperative pain |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction |
Actual Study Start Date : | March 1, 2011 |
Estimated Primary Completion Date : | June 30, 2023 |
Estimated Study Completion Date : | June 30, 2023 |

Arm | Intervention/treatment |
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Experimental: Analgesia options
Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.
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Drug: Fentanyl
0.5, 1 mcg/kg
Other Name: Sublimaze Drug: Acetaminophen Single + Oxycodone
Other Name: Tylenol Drug: Oxycodone With Acetaminophen
Other Name: Percocet |
- Amount of Discomfort [ Time Frame: PACU admission, 15, 30 and 60 min postprocedure, postoperative day 3 ]Change in discomfort following oocyte retrieval with standardized anesthesia management as measured by verbal analogue scoring (0-10 scale). VAS scores correlate to minimal (VAS 0-3), moderate (VAS 4-6) or severe (VAS ≥7) discomfort.
- Amount of Discomfort Following Discharge Until Embryo Transfer [ Time Frame: After 1 hrs but less than 3 days ]Change in discomfort following oocyte retrieval with standardized anesthesia management as measured by verbal analogue scoring (0-10 scale) after immediate postoperative period (1 hrs) but prior to Embryo Transfer on 3rd postoperative day. Visual Analogue Scale (VAS) scores correlate to minimal (VAS 0-3), moderate (VAS 4-6) or severe (VAS ≥7) discomfort. Patients will record the type, dose, and timing of pain medicines in a diary to be returned at Embryo Transfer.

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) I to III health status (moderate systemic disease),
- Age between 18 and 50 yrs
- Undergoing oocyte retrieval with intravenous general anesthesia.
Exclusion Criteria:
- Refuse or withdraw their consent
- Fail to adequately respond to IVF stimulations medications, and thus are not eligible for oocyte retrieval.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03105518
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Lawrence C Tsen, MD | Brigham and Women's Hospital |
Documents provided by Lawrence Ching Tsen, Brigham and Women's Hospital:
Responsible Party: | Lawrence Ching Tsen, Vice Chair, Faculty Development and Education; Associate Professor, Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT03105518 |
Other Study ID Numbers: |
2010-P-002310/1 |
First Posted: | April 10, 2017 Key Record Dates |
Results First Posted: | December 5, 2017 |
Last Update Posted: | August 3, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
assisted reproduction postoperative pain opioid |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Acetaminophen Fentanyl Oxycodone Analgesics, Opioid Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Non-Narcotic Antipyretics |