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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
Not applicable
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
The purpose of this study is to see whether injecting local anaesthetic into the vaginal tissues,just prior to transvaginal egg collection,will decrease the amount of pain experienced by women having their eggs collected on an IVF cycle. All women will also receive intravenous sedation as required as well as a sleeping tablet thirty minutes prior to the procedure which is our routine procedure for egg collection.
Trial website
https://clinicaltrials.gov/study/NCT00554424
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00554424