A Non-inferiority Trial on Pain Relief During Oocyte Retrieval
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the trial is to compare fentanyl and midazolam vs diazepam and pethidine in
      terms of the pain levels and post-operative side effects of TUGOR
    

Detailed description: 
      In-vitro fertilization / embryo transfer (IVF / ET) is a well-established method to treat
      various causes of infertility. It involves multiple follicular development, retrieval of
      oocytes and embryo transfer after fertilization. Egg retrieval at the majority of IVF units
      is performed through the transvaginal route under ultrasound guidance (TUGOR) [1]. During
      TUGOR, the needle has to pass through the mucosa in the vaginal vault in order to puncture
      the follicles in the ovary. The procedures are generally short, lasting about 20-30 minutes
      but are still painful without anaesthesia or analgesia.

      Intravenous sedation with or without local anaesthesia is the most widely used method.
      Conscious sedation is a safe and cost-effective method of providing analgesia and anesthesia
      for TUGOR. [2] It is easy to administer in cooperative and motivated patients. It has a
      relatively low risk for adverse effects on oocyte and embryo quality and pregnancy rates. [3]
      Paracervical block (PCB) in conjunction with conscious sedation during TUGOR was shown to
      significantly reduce the pain during TUGOR when compared to PCB alone [4].

      A Cochrane review on various methods of sedation and analgesia for pain relief during TUGOR
      has shown no single method or delivery system appeared superior for pregnancy rates and pain
      relief. [5] Most of the methods seemed to work well and the effect was usually enhanced by
      addition of another method such as pain relief with paracervical block. [6]

      The investigators' reproductive centre has recently aligned with the Assisted Reproduction
      Centre of the University of Hong Kong (HKU). The investigators are using 0.1mg fentanyl and
      5mg midazolam intravenously for pain relief in TUGOR at Kwong Wah Hospital (KWH) whereas 5mg
      diazepam and 25mg pethidine intravenously are being used in HKU. The investigators would like
      to compare fentanyl and midazolam vs diazepam and pethidine in terms of pain levels and
      post-operative side effects of TUGOR in this prospective non-inferiority randomized
      double-blinded trial. The investigators postulate there are no differences in the pain levels
      between two groups but the postoperative side effects may be different.
    

Intervention name(s): fentanyl; pethidine; Diazepam; Midazolam
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): arm A receiving iv fentanyl; arm B receiving iv pethidine; arm B receiving iv diazepam; arm A receiving iv midazolam
Other intervention name(s): valium; dormicum
Intervention MeSH terms: Midazolam; Fentanyl; Diazepam; Meperidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: fentanyl; midazolam; pethidine; diazepam