Clinical trial NCT02494180: A Non-inferiority Trial on Pain Relief During Oocyte Retrieval
Official title: A Prospective, Non-inferiority Randomized Double-blinded Trial Comparing Fentanyl and Midazolam vs Diazepam and Pethidine for Pain Relief During Oocyte Retrieval
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: fentanyl
midazolam
pethidine
diazepam
Lead sponsor: Kwong Wah Hospital
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
name: Queen Mary Hospital, Hong Kong
First posted: 2015-07-10
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* presence of both ovaries;
* body mass index less than 30
* written informed consent and
* Chinese

Exclusion Criteria:

* IVF cycle converted from ovulation induction or intrauterine insemination cycles;
* patient requests general anaesthesia for TUGOR;
* history of drug sensitivity to lignocaine/fentanyl/midazolam/diazepam/pethidine;
* less than 3 dominant follicles present;
* dominant follicles present in one ovary only and
* TUGOR performed on one side only.

Primary outcomes:
measure: Pain Level During Oocyte Retrieval
timeFrame: will be assessed within 4 hours of oocyte retrieval
measure: Pain Level After Oocyte Retrieval
timeFrame: will be assessed within 4 hours of oocyte retrieval
Secondary outcomes:
measure: Percentage of Participants With Side Effects by Type
timeFrame: will be assessed within 4 hours of oocyte retrieval
measure: Patient's Satisfaction on Oocyte Retrieval
timeFrame: will be assessed within 4 hours of oocyte retrieval
measure: Clinical Pregnancy Rate
timeFrame: will be assessed within ten weeks of oocyte retrieval
measure: Ongoing Pregnancy Rate
timeFrame: will be assessed within ten weeks of oocyte retrieval
measure: Patient's Satisfaction on Pain Relief
timeFrame: within 4 hours after retrieval
measure: Sedation Level
timeFrame: immediately after retrieval
Other outcomes:
Locations:
Study officials:
affiliation: Kwong Wah Hospital
name: Shui Fan Lai
role: PRINCIPAL_INVESTIGATOR
References: