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Local Anaesthetic for Transvaginal Egg Collection in IVF

Primary Purpose

Infertility

Status

Completed

Phase

Not Applicable

Locations

New Zealand

Study Type

Interventional

Intervention

lignocaine

normal saline

About this trial

This is an interventional supportive care trial for Infertility focused on measuring oocyte retrieval, pain relief, Local anaesthetic

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

The Fertility Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

Total dose of iv fentanyl used during oocyte collection

Secondary Outcome Measures

Pain score (cm on a Visual Analogue Scale) at 6 different points during oocyte collection

Length of oocyte collection procedure

Occurence of nausea or vomiting

Administration of atropine or anti -emetic

Time spent in recovery room

No of oocytes collected

Number of oocytes fertilised

Pregnancy outcome

Number of embryos frozen

Pulse rate at beginning and end of egg collection

Maximum pulse rate during oocyte collection

Full Information

NCT ID

NCT00554424

First Posted

November 3, 2007

Last Updated

November 5, 2007

Sponsor

The Fertility Centre, New Zealand

1. Study Identification

Unique Protocol Identification Number

NCT00554424

Brief Title

Local Anaesthetic for Transvaginal Egg Collection in IVF

Official Title

A Randomised Controlled Trial of Intravaginal Lignocaine Injection Versus Placebo for Analgesia During Oocyte Recovery in an IVF Cycle

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Completed

Study Start Date

March 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

The Fertility Centre, New Zealand

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

oocyte retrieval, pain relief, Local anaesthetic

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

lignocaine

Intervention Description

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

Intervention Name(s)

normal saline

Intervention Description

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

Primary Outcome Measure Information:

Title

Total dose of iv fentanyl used during oocyte collection

Time Frame

Length of oocyte collection (minutes)

Secondary Outcome Measure Information:

Title

Pain score (cm on a Visual Analogue Scale) at 6 different points during oocyte collection

Time Frame

Actual point in time

Title

Length of oocyte collection procedure

Time Frame

Time taken (minutes)

Title

Occurence of nausea or vomiting

Time Frame

During oocyte collection procedure

Title

Administration of atropine or anti -emetic

Time Frame

During oocyte collection procedure

Title

Time spent in recovery room

Time Frame

Time from end of oocyte collection until discharge home

Title

No of oocytes collected

Time Frame

During oocyte collection procedure

Title

Number of oocytes fertilised

Time Frame

Assessed 18 hours after oocyte collection

Title

Pregnancy outcome

Time Frame

7 weeks gestation

Title

Number of embryos frozen

Time Frame

Within 6 days of oocyte collection

Title

Pulse rate at beginning and end of egg collection

Time Frame

Point in time

Title

Maximum pulse rate during oocyte collection

Time Frame

Point in time during oocyte collection procedure

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sarah A Wakeman, FRANZCOG

Organizational Affiliation

The Fertility Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Fertility Centre

City

Christchurch

State/Province

Canterbury

ZIP/Postal Code

8014

Country

New Zealand

12. IPD Sharing Statement

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Local Anaesthetic for Transvaginal Egg Collection in IVF

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