NCT03105518

Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The central objective of this study will be to evaluate the relationship between estrogen levels and the pain following oocyte retrieval in women undergoing in vitro fertilization.

Detailed description

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.

Conditions

• Oocyte Retrieval
• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Fentanyl	0.5, 1 mcg/kg
DRUG	Acetaminophen	Single + Oxycodone
DRUG	Oxycodone	With Acetaminophen

Timeline

• Start date: 2011-03-01
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2017-04-10
• Last updated: 2022-08-03
• Results posted: 2017-12-05

Locations

1 site across 1 country: United States