Local Anaesthetic for Transvaginal Egg Collection in IVF

Study Overview
=================
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.

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

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: lignocaine
* Drug: normal saline


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LA<br>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<br>* 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<br>|
| Placebo Comparator: P<br>Intravaginal saline placebo injection into each side of upper vagina under ultrasound guidance immediately prior to transvaginal oocyte retrieval | Drug: normal saline<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose of iv fentanyl used during oocyte collection |  | Length of oocyte collection (minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| No of oocytes collected |  | During oocyte collection procedure | 
| Number of oocytes fertilised |  | Assessed 18 hours after oocyte collection | 
| Pregnancy outcome |  | 7 weeks gestation | 
| Number of embryos frozen |  | Within 6 days of oocyte collection | 
| Pulse rate at beginning and end of egg collection |  | Point in time | 
| Maximum pulse rate during oocyte collection |  | Point in time during oocyte collection procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oocyte retrieval, pain relief, Local anaesthetic