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Completed

NCT Number: NCT00554424

Local Anaesthetic for Transvaginal Egg Collection in IVF

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Fertility Centre

Christchurch, Canterbury, 8014, New Zealand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Total dose of iv fentanyl used during oocyte collection

    Time frame: Length of oocyte collection (minutes)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

The Fertility Centre, New Zealand

Other

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2002
First posted
Nov 6, 2007
Registry last updated
Nov 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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