Optimizing Patient Analgesic Experience During IVF
|ClinicalTrials.gov Identifier: NCT01814657|
Recruitment Status : Unknown
Verified December 2014 by Tarek Motan, University of Alberta.
Recruitment status was: Recruiting
First Posted : March 20, 2013
Last Update Posted : January 1, 2015
This study is for patients undergoing In Vitro Fertilization (IVF). The investigators are studying the best way to control pain during the egg retrieval process. The egg retrieval involves passing a needle under ultrasound guidance through the vagina into the ovaries to remove eggs that are to be later fertilized. Patients often report this as very uncomfortable.
Different fertility clinics across the country use different methods of pain control. All clinics will use intravenous medication to control pain, while some may or may not use local anaesthetic (freezing) in the vagina. Our goal is to find the best way to control pain. Since local anaesthetic injection involves multiple needle punctures and may be painful, the investigators are unsure if local anaesthetic is necessary in addition to the intravenous pain medication.
The investigators will conduct a randomized trial where all patients will receive intravenous pain medication, but some will receive local anaesthetic injection and some will receive placebo injection. Patients will be asked to complete a questionnaire on their pain experience after oocyte retrieval. The investigators will then analyze the data and determine whether local anaesthetic actually improves pain when patients are already receiving intravenous pain medications. Through our study, the investigators aim to improve the pain experience of all women undergoing IVF in the future.
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Drug: Lidocaine hydrochloride (HCl) 1% solution Drug: Sterile Normal Saline%||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||308 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Optimizing Patient Analgesic Experience During IVF|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
Placebo Comparator: Normal Saline
Conscious sedation and sterile normal saline (placebo) paracervical block
Drug: Sterile Normal Saline%
Sterile normal saline used as placebo for lidocaine hydrochloride (HCl)1% solution
Other Name: Sterile Normal Saline
Active Comparator: Lidocaine
Conscious sedation and Lidocaine hydrochloride 1% solution paracervical block
Drug: Lidocaine hydrochloride (HCl) 1% solution
Comparison of paracervical block using Lidocaine versus Normal Saline placebo in patients undergoing oocyte retrieval during IVF.
Other Name: Xylocaine
- Pain scores rated on SF-MPQ [ Time Frame: Data collection is scheduled to proceed until 308 participants have been recruited which is anticipated to take up to 2 years. ]Score rating will be done before the patient is discharged following oocyte retrieval.
- Embryology data [ Time Frame: Assessed within 7 days of oocyte retrieval ]Recorded as number of embryos obtained. Number of embryos transferred. The decision to transfer Day 3 embryos or Day 5 blastocysts. Number of embryos or blastocysts frozen. Embryological grading of all embryos or blastocysts either transferred or frozen.
- Live Birth Rates [ Time Frame: Within 12 months of oocyte retrieval ]Recorded as the number of infants born alive to the patient that resulted from embryos transferred during this study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01814657
|Fertility and Womens Endocrine Clinic||Recruiting|
|Edmonton, Alberta, Canada, T5H 3V9|
|Contact: Tarek Motan, MB ChB 780-735-5604|
|Principal Investigator: Tarek Motan, MB ChB|
|Sub-Investigator: Tom Gotz, MD|
|Principal Investigator:||Tarek Motan, MB ChB||University of Alberta|