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A Non-inferiority Trial on Pain Relief During Oocyte Retrieval

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ClinicalTrials.gov Identifier: NCT02494180
Recruitment Status : Completed
First Posted : July 10, 2015
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborators:
The University of Hong Kong
Queen Mary Hospital, Hong Kong
Information provided by (Responsible Party):
lydia lai, Kwong Wah Hospital

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

Condition or disease Intervention/treatment Phase
Infertility Drug: fentanyl Drug: pethidine Drug: Diazepam Drug: Midazolam Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: A Prospective, Non-inferiority Randomized Double-blinded Trial Comparing Fentanyl and Midazolam vs Diazepam and Pethidine for Pain Relief During Oocyte Retrieval
Actual Study Start Date : March 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: A: intravenous fentanyl, midazolam
group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval
Drug: fentanyl
arm A receiving iv fentanyl

Drug: Midazolam
arm A receiving iv midazolam
Other Name: dormicum

Placebo Comparator: B: intravenous pethidine, diazepam
group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval
Drug: pethidine
arm B receiving iv pethidine

Drug: Diazepam
arm B receiving iv diazepam
Other Name: valium




Primary Outcome Measures :
  1. Pain Level During Oocyte Retrieval [ Time Frame: will be assessed within 4 hours of oocyte retrieval ]
    The pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful

  2. Pain Level After Oocyte Retrieval [ Time Frame: will be assessed within 4 hours of oocyte retrieval ]
    The pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful


Secondary Outcome Measures :
  1. Percentage of Participants With Side Effects by Type [ Time Frame: will be assessed within 4 hours of oocyte retrieval ]
    side effects will be scored by yes or no

  2. Patient's Satisfaction on Oocyte Retrieval [ Time Frame: will be assessed within 4 hours of oocyte retrieval ]
    satisfaction will be scored from 0-3 (0=excellent, 1=satisfactory, 2=fair, 3=unsatisfactory)

  3. Clinical Pregnancy Rate [ Time Frame: will be assessed within ten weeks of oocyte retrieval ]
    presence of intrauterine sac in ultrasound after a positive pregnancy test

  4. Ongoing Pregnancy Rate [ Time Frame: will be assessed within ten weeks of oocyte retrieval ]
    positive fetal heart pulsation seen in ultrasound at eight weeks of gestation

  5. Patient's Satisfaction on Pain Relief [ Time Frame: within 4 hours after retrieval ]
    satisfaction on pain relief will be scored at 0-10 (10 being most satisfied)

  6. Sedation Level [ Time Frame: immediately after retrieval ]
    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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494180


Sponsors and Collaborators
Kwong Wah Hospital
The University of Hong Kong
Queen Mary Hospital, Hong Kong
Investigators
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Principal Investigator: Shui Fan Lai Kwong Wah Hospital
  Study Documents (Full-Text)

Documents provided by lydia lai, Kwong Wah Hospital:

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Responsible Party: lydia lai, Associate Consultant, Kwong Wah Hospital
ClinicalTrials.gov Identifier: NCT02494180     History of Changes
Other Study ID Numbers: KW/FR-15-021(83-22)
First Posted: July 10, 2015    Key Record Dates
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019
Last Verified: February 2019
Keywords provided by lydia lai, Kwong Wah Hospital:
fentanyl
midazolam
pethidine
diazepam
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Fentanyl
Midazolam
Diazepam
Meperidine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Antiemetics
Autonomic Agents
Gastrointestinal Agents