Infertility Clinical Trial
Official title:
A Prospective, Non-inferiority Randomized Double-blinded Trial Comparing Fentanyl and Midazolam vs Diazepam and Pethidine for Pain Relief During Oocyte Retrieval
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
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.
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