Local Anaesthetic for Transvaginal Egg Collection in IVF

This study has been completed.
Sponsor:
Information provided by:
The Fertility Centre, New Zealand
ClinicalTrials.gov Identifier:
NCT00554424
First received: November 3, 2007
Last updated: November 5, 2007
Last verified: November 2007

November 3, 2007
November 5, 2007
March 2002
Not Provided
Total dose of iv fentanyl used during oocyte collection [ Time Frame: Length of oocyte collection (minutes) ]
Same as current
Complete list of historical versions of study NCT00554424 on ClinicalTrials.gov Archive Site
  • Pain score (cm on a Visual Analogue Scale) at 6 different points during oocyte collection [ Time Frame: Actual point in time ]
  • Length of oocyte collection procedure [ Time Frame: Time taken (minutes) ]
  • Occurence of nausea or vomiting [ Time Frame: During oocyte collection procedure ]
  • Administration of atropine or anti -emetic [ Time Frame: During oocyte collection procedure ]
  • Time spent in recovery room [ Time Frame: Time from end of oocyte collection until discharge home ]
  • No of oocytes collected [ Time Frame: During oocyte collection procedure ]
  • Number of oocytes fertilised [ Time Frame: Assessed 18 hours after oocyte collection ]
  • Pregnancy outcome [ Time Frame: 7 weeks gestation ]
  • Number of embryos frozen [ Time Frame: Within 6 days of oocyte collection ]
  • Pulse rate at beginning and end of egg collection [ Time Frame: Point in time ]
  • Maximum pulse rate during oocyte collection [ Time Frame: Point in time during oocyte collection procedure ]
Same as current
Not Provided
Not Provided
 
Local Anaesthetic for Transvaginal Egg Collection in IVF
A Randomised Controlled Trial of Intravaginal Lignocaine Injection Versus Placebo for Analgesia During Oocyte Recovery in an IVF Cycle

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.

Transvaginal oocyte retrieval is the most common method of oocyte collection in IVF cycles. A variety of different methods are used to provide analgesia/anesthesia for oocyte collection. Our unit has always used an oral pre-medication followed by intravenous fentanyl during the procedure but this doesn't seem to provide adequate analgesia for some women. The aim of this study was to compare the addition of intravaginal local anaesthetic injection versus saline placebo to our usual analgesia regime to see whether less intravenous fentanyl was required and whether the women experienced less pain during oocyte collection.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Infertility
  • Drug: 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
  • Drug: 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
  • 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
    Intervention: Drug: lignocaine
  • Placebo Comparator: P
    Intravaginal saline placebo injection into each side of upper vagina under ultrasound guidance immediately prior to transvaginal oocyte retrieval
    Intervention: Drug: normal saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
July 2002
Not Provided

Inclusion Criteria:

  • About to undergo transvaginal oocyte retrieval

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
New Zealand
 
NCT00554424
01/12/180
Yes
Not Provided
The Fertility Centre, New Zealand
Not Provided
Principal Investigator: Sarah A Wakeman, FRANZCOG The Fertility Centre
The Fertility Centre, New Zealand
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP