ClinicalTrials.gov
ClinicalTrials.gov Menu

Local Anaesthetic for Transvaginal Egg Collection in IVF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00554424
Recruitment Status : Completed
First Posted : November 6, 2007
Last Update Posted : November 6, 2007
Sponsor:
Information provided by:
The Fertility Centre, New Zealand

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Infertility Drug: lignocaine Drug: normal saline Not Applicable

Detailed Description:
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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomised Controlled Trial of Intravaginal Lignocaine Injection Versus Placebo for Analgesia During Oocyte Recovery in an IVF Cycle
Study Start Date : March 2002
Actual Study Completion Date : July 2002

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
 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
Placebo Comparator: P
Intravaginal saline placebo injection into each side of upper vagina under ultrasound guidance immediately prior to transvaginal oocyte retrieval
 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Total dose of iv fentanyl used during oocyte collection [ Time Frame: Length of oocyte collection (minutes) ]

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00554424


Locations
New Zealand
The Fertility Centre
Christchurch, Canterbury, New Zealand, 8014
Sponsors and Collaborators
The Fertility Centre, New Zealand
Investigators
Principal Investigator: Sarah A Wakeman, FRANZCOG The Fertility Centre
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00554424     History of Changes
Other Study ID Numbers: 01/12/180
First Posted: November 6, 2007    Key Record Dates
Last Update Posted: November 6, 2007
Last Verified: November 2007

Keywords provided by The Fertility Centre, New Zealand:
oocyte retrieval
pain relief
Local anaesthetic

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Anesthetics
Lidocaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
 Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action