Local Anaesthetic for Transvaginal Egg Collection in IVF
This study has been completed.
Sponsor:
The Fertility Centre, New Zealand
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
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Purpose
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 | Intervention |
|---|---|
|
Infertility |
Drug: lignocaine Drug: normal saline |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by The Fertility Centre, New Zealand:
Primary Outcome Measures:
- Total dose of iv fentanyl used during oocyte collection [ Time Frame: Length of oocyte collection (minutes) ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 75 |
| Study Start Date: | March 2002 |
| Study Completion Date: | July 2002 |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00554424 History of Changes |
| Other Study ID Numbers: | 01/12/180 |
| Study First Received: | November 3, 2007 |
| Last Updated: | November 5, 2007 |
| Health Authority: | New Zealand: Health and Disability Ethics Committees |
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, Local Lidocaine Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013