Optimizing Patient Analgesic Experience During IVF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Tarek Motan, University of Alberta

Brief Summary:

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
Infertility Drug: Lidocaine hydrochloride (HCl) 1% solution Drug: Sterile Normal Saline%

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Other Outcome Measures:
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   21 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Women undergoing oocyte retrieval who have consented to participation
  • Only the first ART cycle will be included

Exclusion Criteria:

  • History of drug sensitivity to local anaesthetic agents
  • Women with any chronic pain syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01814657

Canada, Alberta
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         
Sponsors and Collaborators
University of Alberta
Principal Investigator: Tarek Motan, MB ChB University of Alberta


Responsible Party: Tarek Motan, Associate Professor, University of Alberta Identifier: NCT01814657     History of Changes
Other Study ID Numbers: 00029750
First Posted: March 20, 2013    Key Record Dates
Last Update Posted: January 1, 2015
Last Verified: December 2014

Keywords provided by Tarek Motan, University of Alberta:

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Pharmaceutical Solutions
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