2025-523018-10-00
尚未招募
Phase III and phase IV (Integrated)
Evaluation of a New Pain Management Regime for Oocyte Pick-Up During Fertility Treatment
概览
- 阶段
- Phase III and phase IV (Integrated)
- 状态
- 尚未招募
- 发起方
- UZ Brussel
- 入组人数
- 318
- 试验地点
- 1
- 主要终点
- Overall intra-procedural pain intensity during OPU, VAS 0–100 mm recorded every 2 minutes from first puncture to completion; primary derived measure (mean/median or VAS-AUC over time) per SAP.
概览
简要总结
To demonstrate that a single pre-procedure dose of sublingual sufentanil 30 µg (Dzuveo) reduces intra-procedural pain during oocyte pick-up compared with the standard midazolam-based regimen, measured by repeated VAS (0–100 mm) scores recorded every two minutes throughout the procedure.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female adult undergoing IVF/ART with a planned transvaginal oocyte pick-up at UZ Brussel.
- •Able to provide informed consent and comply with study procedures (pain ratings during OPU; 24-h follow-up).
- •ASA physical status I–III under institutional OPU sedation/analgesia pathways.
- •Meets institutional safety thresholds for ambulatory OPU (e.g., airway assessment, BMI and comorbidity limits) per site SOPs.
排除标准
- •Hypersensitivity to sufentanil/opioids, midazolam/benzodiazepines, paracetamol, diclofenac/NSAIDs, lidocaine, or excipients.
- •Current use of MAOIs or within 14 days pre-OPU.
- •History of substance abuse (opioids/benzodiazepines) within the past year.
- •Inability to provide informed consent/communicate effectively, or any condition that increases risk or could confound results per investigator judgement.
- •Any SmPC contraindication to sufentanil (e.g., severe respiratory depression; acute/severe asthma in an unmonitored setting or without resuscitative equipment; known/suspected GI obstruction incl. paralytic ileus).
- •Any SmPC contraindication to midazolam (e.g., severe respiratory insufficiency, severe hepatic impairment, myasthenia gravis, sleep apnoea).
- •Contraindications to paracetamol or diclofenac (e.g., active GI bleeding/ulceration, severe hepatic or renal impairment, severe heart failure).
- •Chronic pain condition requiring regular analgesics
- •Severe anxiety disorder/panic disorder or other significant psychiatric disorder likely to interfere with participation or pain assessment.
- •OPU planned under general anaesthesia.
结局指标
主要结局
Overall intra-procedural pain intensity during OPU, VAS 0–100 mm recorded every 2 minutes from first puncture to completion; primary derived measure (mean/median or VAS-AUC over time) per SAP.
Overall intra-procedural pain intensity during OPU, VAS 0–100 mm recorded every 2 minutes from first puncture to completion; primary derived measure (mean/median or VAS-AUC over time) per SAP.
次要结局
- Patient satisfaction with pain management at ~24 h post-OPU using APS-POQ-R.
- Post-OPU VAS pain at T0 (arrival in recovery), 30 min, 1 h, and discharge.
- Rescue analgesic use at home within 24 h (type/amount).
- Nausea/vomiting incidence: pre-OPU, immediate post-OPU, 30 min, 1 h, discharge, and at 24 h.
- Respiratory depression/other AEs during and immediately after OPU (SpO₂, RR, clinical observation).
- Vaginal bleeding (usual/less/more than usual).
- Recovery metrics: time to discharge, procedure duration, number of oocytes retrieved, operator experience level.
- Hormonal/fertility markers: E2/FSH/LH/progesterone and follicle count (2 days pre-OPU); HCG 2 weeks post-ET; clinical pregnancy at ~7 weeks.
研究者
Annelies Scholliers
Scientific
UZ Brussel
研究点 (1)
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