Local Anaesthetic for Transvaginal Egg Collection in IVF

Sponsor

The Fertility Centre, New Zealand (Other)

Overall Status

Completed

CT.gov ID

NCT00554424

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

18.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

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 :

Mar 1, 2002

Actual Study Completion Date :

Jul 1, 2002

Arms and Interventions

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

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

Primary Outcome Measures

Total dose of iv fentanyl used during oocyte collection [Length of oocyte collection (minutes)]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00554424

Other Study ID Numbers:

01/12/180

First Posted:

Nov 6, 2007

Last Update Posted:

Nov 6, 2007

Last Verified:

Nov 1, 2007

Keywords provided by , ,

oocyte retrieval

pain relief

Local anaesthetic

Additional relevant MeSH terms:

Infertility

Lidocaine

Study Results

No Results Posted as of Nov 6, 2007