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Optimizing Patient Analgesic Experience During IVF

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by Tarek Motan, University of Alberta.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Tarek Motan, University of Alberta Identifier:
First received: March 8, 2013
Last updated: December 31, 2014
Last verified: December 2014

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Tarek Motan, University of Alberta:

Primary Outcome Measures:
  • 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:
  • 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:
  • 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.

Estimated Enrollment: 308
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information


Responsible Party: Tarek Motan, Associate Professor, University of Alberta Identifier: NCT01814657     History of Changes
Other Study ID Numbers: 00029750
Study First Received: March 8, 2013
Last Updated: December 31, 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 processed this record on August 18, 2017