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Local Anaesthetic for Transvaginal Egg Collection in IVF

NCT ID: NCT00554424

Last Updated: 2007-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2002-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infertility

Keywords

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oocyte retrieval pain relief Local anaesthetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

lignocaine

Intervention Type DRUG

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

P

Intravaginal saline placebo injection into each side of upper vagina under ultrasound guidance immediately prior to transvaginal oocyte retrieval

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Fertility Centre, New Zealand

OTHER

Sponsor Role lead

Principal Investigators

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Sarah A Wakeman, FRANZCOG

Role: PRINCIPAL_INVESTIGATOR

The Fertility Centre

Locations

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The Fertility Centre

Christchurch, Canterbury, New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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01/12/180

Identifier Type: -

Identifier Source: org_study_id