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Optimizing Patient Analgesic Experience During IVF

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
Tarek Motan, University of Alberta
ClinicalTrials.gov Identifier:
NCT01814657
First received: March 8, 2013
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   21 Years to 43 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01814657

Locations
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
Investigators
Principal Investigator: Tarek Motan, MB ChB University of Alberta
  More Information

Publications:
Harrison, R.F., Barry-Kinsella, C., Drury, L., Gordon, A., Hannon, K., Hennelly, B., Keogh, I., Kondaveeti, U., Nargund, G., Verso, J. (1992) An Irish out-patient based in vitro fertisation service. Irish Medical Journal. 85 63-65

Responsible Party: Tarek Motan, Associate Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01814657     History of Changes
Other Study ID Numbers: 00029750
Study First Received: March 8, 2013
Last Updated: September 17, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Infertility

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male
Analgesics
Lidocaine
Pharmaceutical Solutions
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 27, 2014