Local Anaesthetic for Transvaginal Egg Collection in IVF

NCT00554424 | Completed DMC

• 1 other identifier: 01/12/180
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

oocyte retrieval; pain relief; Local anaesthetic

Outcome Measures

Primary Outcomes (1)

• Total dose of iv fentanyl used during oocyte collection

  Length of oocyte collection (minutes)

Secondary Outcomes (11)

• 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

Study Arms (2)

LA

ACTIVE COMPARATOR

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

P

PLACEBO COMPARATOR

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

Drug: normal saline

Interventions

lignocaine 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

LA

normal saline 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

P

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• About to undergo transvaginal oocyte retrieval

You may not qualify if:

• 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

Sponsors & Collaborators

• The Fertility Centre, New Zealand: lead

Study Sites (1)

The Fertility Centre

Christchurch, Canterbury, 8014, New Zealand

Location

MeSH Terms

Conditions

Infertility

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Sarah A Wakeman, FRANZCOG

  The Fertility Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 3, 2007
• First Posted: November 6, 2007
• Study Start: March 1, 2002
• Study Completion: July 1, 2002
• Last Updated: November 6, 2007

Record last verified: 2007-11

Locations

NZ (1)