NCT02494180

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 5, 2019

Completed
Last Updated

March 5, 2019

Status Verified

February 1, 2019

Enrollment Period

1.9 years

First QC Date

June 17, 2015

Results QC Date

January 2, 2019

Last Update Submit

February 11, 2019

Conditions

Infertility

Keywords

fentanylmidazolampethidinediazepam

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • Percentage of Participants With Side Effects by Type

    will be assessed within 4 hours of oocyte retrieval

  • Patient's Satisfaction on Oocyte Retrieval

    will be assessed within 4 hours of oocyte retrieval

  • Clinical Pregnancy Rate

    will be assessed within ten weeks of oocyte retrieval

  • Ongoing Pregnancy Rate

    will be assessed within ten weeks of oocyte retrieval

  • Patient's Satisfaction on Pain Relief

    within 4 hours after retrieval

  • +1 more secondary outcomes

Study Arms (2)

A: intravenous fentanyl, midazolam

PLACEBO COMPARATOR

group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval

Drug: fentanylDrug: Midazolam

B: intravenous pethidine, diazepam

PLACEBO COMPARATOR

group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval

Drug: pethidineDrug: Diazepam

Interventions

fentanylDRUG

arm A receiving iv fentanyl

A: intravenous fentanyl, midazolam
pethidineDRUG

arm B receiving iv pethidine

B: intravenous pethidine, diazepam
DiazepamDRUG

arm B receiving iv diazepam

Also known as: valium
B: intravenous pethidine, diazepam
MidazolamDRUG

arm A receiving iv midazolam

Also known as: dormicum
A: intravenous fentanyl, midazolam

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility

Interventions

FentanylMeperidineDiazepamMidazolam

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsonipecotic AcidsAcids, HeterocyclicBenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Dr SF Lai
Organization
Kwong Wah Hospital
lsf087@ha.org.hk
85223322311

Study Officials

  • Shui Fan Lai

    Kwong Wah Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Consultant

Study Record Dates

First Submitted

June 17, 2015

First Posted

July 10, 2015

Study Start

March 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

March 5, 2019

Results First Posted

March 5, 2019

Record last verified: 2019-02