A Non-inferiority Trial on Pain Relief During Oocyte Retrieval
Primary Purpose
Infertility
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
fentanyl
pethidine
Diazepam
Midazolam
Sponsored by
About this trial
This is an interventional supportive care trial for Infertility focused on measuring fentanyl, midazolam, pethidine, diazepam
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Placebo Comparator
Arm Label
A: intravenous fentanyl, midazolam
B: intravenous pethidine, diazepam
Arm Description
group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval
group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval
Outcomes
Primary Outcome Measures
Pain Level During Oocyte Retrieval
The pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful
Pain Level After Oocyte Retrieval
The pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful
Secondary Outcome Measures
Percentage of Participants With Side Effects by Type
side effects will be scored by yes or no
Patient's Satisfaction on Oocyte Retrieval
satisfaction will be scored from 0-3 (0=excellent, 1=satisfactory, 2=fair, 3=unsatisfactory)
Clinical Pregnancy Rate
presence of intrauterine sac in ultrasound after a positive pregnancy test
Ongoing Pregnancy Rate
positive fetal heart pulsation seen in ultrasound at eight weeks of gestation
Patient's Satisfaction on Pain Relief
satisfaction on pain relief will be scored at 0-10 (10 being most satisfied)
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
Full Information
NCT ID
NCT02494180
First Posted
June 17, 2015
Last Updated
February 11, 2019
Sponsor
Kwong Wah Hospital
Collaborators
The University of Hong Kong, Queen Mary Hospital, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT02494180
Brief Title
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
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kwong Wah Hospital
Collaborators
The University of Hong Kong, Queen Mary Hospital, Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
fentanyl, midazolam, pethidine, diazepam
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A: intravenous fentanyl, midazolam
Arm Type
Placebo Comparator
Arm Description
group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval
Arm Title
B: intravenous pethidine, diazepam
Arm Type
Placebo Comparator
Arm Description
group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval
Intervention Type
Drug
Intervention Name(s)
fentanyl
Intervention Description
arm A receiving iv fentanyl
Intervention Type
Drug
Intervention Name(s)
pethidine
Intervention Description
arm B receiving iv pethidine
Intervention Type
Drug
Intervention Name(s)
Diazepam
Other Intervention Name(s)
valium
Intervention Description
arm B receiving iv diazepam
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
dormicum
Intervention Description
arm A receiving iv midazolam
Primary Outcome Measure Information:
Title
Pain Level During Oocyte Retrieval
Description
The pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful
Time Frame
will be assessed within 4 hours of oocyte retrieval
Title
Pain Level After Oocyte Retrieval
Description
The pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful
Time Frame
will be assessed within 4 hours of oocyte retrieval
Secondary Outcome Measure Information:
Title
Percentage of Participants With Side Effects by Type
Description
side effects will be scored by yes or no
Time Frame
will be assessed within 4 hours of oocyte retrieval
Title
Patient's Satisfaction on Oocyte Retrieval
Description
satisfaction will be scored from 0-3 (0=excellent, 1=satisfactory, 2=fair, 3=unsatisfactory)
Time Frame
will be assessed within 4 hours of oocyte retrieval
Title
Clinical Pregnancy Rate
Description
presence of intrauterine sac in ultrasound after a positive pregnancy test
Time Frame
will be assessed within ten weeks of oocyte retrieval
Title
Ongoing Pregnancy Rate
Description
positive fetal heart pulsation seen in ultrasound at eight weeks of gestation
Time Frame
will be assessed within ten weeks of oocyte retrieval
Title
Patient's Satisfaction on Pain Relief
Description
satisfaction on pain relief will be scored at 0-10 (10 being most satisfied)
Time Frame
within 4 hours after retrieval
Title
Sedation Level
Description
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
Time Frame
immediately after retrieval
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shui Fan Lai
Organizational Affiliation
Kwong Wah Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
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A Non-inferiority Trial on Pain Relief During Oocyte Retrieval
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