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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00554424




Registration number
NCT00554424
Ethics application status
Date submitted
3/11/2007
Date registered
6/11/2007
Date last updated
6/11/2007

Titles & IDs
Public title
Local Anaesthetic for Transvaginal Egg Collection in IVF
Scientific title
A Randomised Controlled Trial of Intravaginal Lignocaine Injection Versus Placebo for Analgesia During Oocyte Recovery in an IVF Cycle
Secondary ID [1] 0 0
01/12/180
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - lignocaine
Treatment: Drugs - normal saline

Active comparator: LA - Intravaginal and pre-peritoneal injection of 1% lignocaine into each side of the upper vagina under ultrasound guidance immediately prior to ultrasound guided transvaginal oocyte retrieval

Placebo comparator: P - Intravaginal saline placebo injection into each side of upper vagina under ultrasound guidance immediately prior to transvaginal oocyte retrieval


Treatment: Drugs: lignocaine
20 mls of 1% lignocaine solution for injection, 10mls into each side of upper vagina, under ultrasound guidance immediately prior to transvaginal oocyte retrieval under ultrasound guidance from each ovary

Treatment: Drugs: normal saline
20mls of normal saline solution, 10mls injected each side into upper vagina under ultrasound guidance, immediately prior to ultrasound guided transvaginal oocyte retrieval from each ovary
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Total dose of iv fentanyl used during oocyte collection
Timepoint [1] 0 0
Length of oocyte collection (minutes)
Secondary outcome [1] 0 0
Pain score (cm on a Visual Analogue Scale) at 6 different points during oocyte collection
Timepoint [1] 0 0
Actual point in time
Secondary outcome [2] 0 0
Length of oocyte collection procedure
Timepoint [2] 0 0
Time taken (minutes)
Secondary outcome [3] 0 0
Occurence of nausea or vomiting
Timepoint [3] 0 0
During oocyte collection procedure
Secondary outcome [4] 0 0
Administration of atropine or anti -emetic
Timepoint [4] 0 0
During oocyte collection procedure
Secondary outcome [5] 0 0
Time spent in recovery room
Timepoint [5] 0 0
Time from end of oocyte collection until discharge home
Secondary outcome [6] 0 0
No of oocytes collected
Timepoint [6] 0 0
During oocyte collection procedure
Secondary outcome [7] 0 0
Number of oocytes fertilised
Timepoint [7] 0 0
Assessed 18 hours after oocyte collection
Secondary outcome [8] 0 0
Pregnancy outcome
Timepoint [8] 0 0
7 weeks gestation
Secondary outcome [9] 0 0
Number of embryos frozen
Timepoint [9] 0 0
Within 6 days of oocyte collection
Secondary outcome [10] 0 0
Pulse rate at beginning and end of egg collection
Timepoint [10] 0 0
Point in time
Secondary outcome [11] 0 0
Maximum pulse rate during oocyte collection
Timepoint [11] 0 0
Point in time during oocyte collection procedure

Eligibility
Key inclusion criteria
* About to undergo transvaginal oocyte retrieval
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Already undergone oocyte retrieval and participated in study (i.e. 2nd or more oocyte collection procedure during study period)
* Allergy to lignocaine
* Oocytes only to be collected from one ovary
* Procedure expected to be exceptionally painful

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2002
Sample size
Target
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Canterbury

Funding & Sponsors
Primary sponsor type
Other
Name
The Fertility Centre, New Zealand
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sarah A Wakeman, FRANZCOG
Address 0 0
The Fertility Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00554424