Local Anaesthetic for Transvaginal Egg Collection in IVF

Study Description

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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

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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

Arms and Interventions

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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
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