A Non-inferiority Trial on Pain Relief During Oocyte Retrieval

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02494180
• Other study ID #: KW/FR-15-021(83-22)
• Status: Completed
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: February 2018

Study information

• Verified date: February 2019
• Source: Kwong Wah Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• fentanyl
arm A receiving iv fentanyl
• pethidine
arm B receiving iv pethidine
• Diazepam
arm B receiving iv diazepam
• Midazolam
arm A receiving iv midazolam

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Kwong Wah Hospital	Queen Mary Hospital, Hong Kong, The University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Level During Oocyte Retrieval	The pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful	will be assessed within 4 hours of oocyte retrieval
Primary	Pain Level After Oocyte Retrieval	The pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful	will be assessed within 4 hours of oocyte retrieval
Secondary	Percentage of Participants With Side Effects by Type	side effects will be scored by yes or no	will be assessed within 4 hours of oocyte retrieval
Secondary	Patient's Satisfaction on Oocyte Retrieval	satisfaction will be scored from 0-3 (0=excellent, 1=satisfactory, 2=fair, 3=unsatisfactory)	will be assessed within 4 hours of oocyte retrieval
Secondary	Clinical Pregnancy Rate	presence of intrauterine sac in ultrasound after a positive pregnancy test	will be assessed within ten weeks of oocyte retrieval
Secondary	Ongoing Pregnancy Rate	positive fetal heart pulsation seen in ultrasound at eight weeks of gestation	will be assessed within ten weeks of oocyte retrieval
Secondary	Patient's Satisfaction on Pain Relief	satisfaction on pain relief will be scored at 0-10 (10 being most satisfied)	within 4 hours after retrieval
Secondary	Sedation Level	S = sleeping, easily aroused; 1 = awake and alert; 2 = occasionally drowsy, easy to arouse; 3 = frequently drowsy, arousable, drifts off to sleep during conversation; 4 = somnolent, minimal or no response to stimuli	immediately after retrieval