Evaluating the Efficacy of Preoperative Indomethacin and Paracetamol for Pain Management During Oocyte Retrieval in IVF Patients A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity
研究概览
简要总结
This is a randomized controlled trial evaluating the efficacy of preoperative analgesic medications - Indomethacin (100 mg per rectum) and Paracetamol/Acamol (1,000 mg intravenously) - for pain management during oocyte retrieval in women undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
详细描述
Pain during oocyte retrieval is one of the most commonly reported concerns among women undergoing assisted reproductive technology (ART). The procedure involves transvaginal ultrasound-guided aspiration of ovarian follicles, which causes pain through needle puncture of ovarian and surrounding tissues. Adequate analgesia is essential not only for patient comfort but also to minimize procedural stress, reduce the need for deeper sedation, shorten recovery time, and potentially improve treatment outcomes.
Existing analgesic approaches - including paracervical blocks, conscious sedation, and general anesthesia - carry limitations such as hemodynamic risks, prolonged recovery, and increased resource requirements. Randomized controlled trial (RCT) evidence on non-invasive preoperative analgesics for this indication remains limited and methodologically heterogeneous.
This study is a three-arm, randomized, controlled trial comparing two preoperative analgesic regimens against a no-premedication control group in women undergoing oocyte retrieval under standard anesthesia at the IVF Unit, Galilee Medical Centre.
Participants will be randomized to one of three groups:
Group 1: Indomethacin 100 mg per rectum, administered prior to oocyte retrieval Group 2: Paracetamol (Acamol) 1,000 mg intravenously, administered prior to oocyte retrieval Group 3 (Control): No active preoperative analgesic medication
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants are blinded to their treatment allocation. All interventions (Indomethacin per rectum, Paracetamol IV, or no medication) are administered after induction of anesthesia, so participants are unaware of the treatment they received. Investigators and clinical staff are not blinded.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing oocyte retrieval for IVF or ICSI
- •Age 18-45 years
- •ASA physical status classification I or II
- •Willing and able to provide written informed consent
排除标准
- •Known allergy or hypersensitivity to Indomethacin, any NSAID, or Paracetamol
- •History of gastrointestinal bleeding or peptic ulceration
- •Renal impairment (GFR < 30 ml/min/1.73m² or Creatinine > 1.04 mg/dL)
- •Hepatic impairment (ALT > 55 U/L, AST > upper limit of normal, ALP > upper limit of normal, Total Bilirubin > 1.2 mg/dL, or Albumin < 3.5 g/dL)
- •Participation in another clinical trial that may interfere with the outcomes of this study
研究组 & 干预措施
Indomethacin Group
Participants receive Indomethacin 100 mg per rectum, administered after induction of anesthesia prior to oocyte retrieval.
干预措施: Indomethacin 100Mg Suppository (Drug)
Paracetamol Group
Participants receive Paracetamol (Acamol) 1,000 mg intravenously, administered after induction of anesthesia prior to oocyte retrieval. Paracetamol Group
干预措施: Paracetamol / Acetaminophen (Drug)
Control Group
Participants receive no active preoperative analgesic medication. Oocyte retrieval is performed under standard anesthesia protocols only.
结局指标
主要结局
Postoperative Pain Intensity
时间窗: From immediately post-procedure up to 3 days after oocyte retrieval
Pain intensity assessed using the Numerical Rating Scale (NRS), where 0 = no pain and 10 = worst imaginable pain. Pain is measured immediately after the procedure, every 15 minutes for 2 hours post-retrieval, prior to discharge, and 1-3 days after oocyte retrieval. Scores are compared across the three study arms.
次要结局
未报告次要终点
研究者
raneen sawaid
Medical Doctor, Fertility Specialist and head of fertility preservation unit
Western Galilee Hospital-Nahariya