NCT01814657

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
308

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 20, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2015

Completed
Last Updated

July 18, 2022

Status Verified

December 1, 2014

Enrollment Period

2.7 years

First QC Date

March 8, 2013

Last Update Submit

July 14, 2022

Conditions

Infertility

Keywords

Infertility

Outcome Measures

Primary Outcomes (1)

  • Pain scores rated on SF-MPQ

    Score rating will be done before the patient is discharged following oocyte retrieval.

    Data collection is scheduled to proceed until 308 participants have been recruited which is anticipated to take up to 2 years.

Secondary Outcomes (1)

  • Embryology data

    Assessed within 7 days of oocyte retrieval

Other Outcomes (1)

  • Live Birth Rates

    Within 12 months of oocyte retrieval

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

Conscious sedation and sterile normal saline (placebo) paracervical block

Drug: Sterile Normal Saline%

Lidocaine

ACTIVE COMPARATOR

Conscious sedation and Lidocaine hydrochloride 1% solution paracervical block

Drug: Lidocaine hydrochloride (HCl) 1% solution

Interventions

Lidocaine hydrochloride (HCl) 1% solutionDRUG

Comparison of paracervical block using Lidocaine versus Normal Saline placebo in patients undergoing oocyte retrieval during IVF.

Also known as: Xylocaine
Lidocaine
Sterile Normal Saline%DRUG

Sterile normal saline used as placebo for lidocaine hydrochloride (HCl)1% solution

Also known as: Sterile Normal Saline
Normal Saline

Eligibility Criteria

Age21 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility and Womens Endocrine Clinic

Edmonton, Alberta, T5H 3V9, Canada

Location

Related Publications (10)

  • Ng EH, Tang OS, Chui DK, Ho PC. A prospective, randomized, double-blind and placebo-controlled study to assess the efficacy of paracervical block in the pain relief during egg collection in IVF. Hum Reprod. 1999 Nov;14(11):2783-7. doi: 10.1093/humrep/14.11.2783.

    PMID: 10548622BACKGROUND

  • Bhattacharya S, MacLennan F, Hamilton MP, Templeton A. How effective is patient-controlled analgesia? A randomized comparison of two protocols for pain relief during oocyte recovery. Hum Reprod. 1997 Jul;12(7):1440-2. doi: 10.1093/humrep/12.7.1440.

    PMID: 9262274BACKGROUND

  • Elkington NM, Kehoe J, Acharya U. Intravenous sedation in assisted conception units: a UK survey. Hum Fertil (Camb). 2003 May;6(2):74-6. doi: 10.1080/1464770312331369083.

    PMID: 12869788BACKGROUND

  • Bokhari A, Pollard BJ. Anaesthesia for assisted conception: a survey of UK practice. Eur J Anaesthesiol. 1999 Apr;16(4):225-30. doi: 10.1046/j.1365-2346.1999.00461.x.

    PMID: 10234491BACKGROUND

  • Vlahos NF, Giannakikou I, Vlachos A, Vitoratos N. Analgesia and anesthesia for assisted reproductive technologies. Int J Gynaecol Obstet. 2009 Jun;105(3):201-5. doi: 10.1016/j.ijgo.2009.01.017. Epub 2009 Feb 26.

    PMID: 19249049BACKGROUND

  • Sephton VC, Shaw A, Cowan CM, Thomas K, Wood S, Barclay PM, Kingsland CR. Sedation and analgesia for transvaginal oocyte retrieval: an audit resulting in a change of clinical practice. Hum Fertil (Camb). 2001;4(2):94-8. doi: 10.1080/1464727012000199361.

    PMID: 11591263BACKGROUND

  • Harrison RF, Barry-Kinsella C, Drudy L, Gordon A, Hannon K, Hennelly B, Keogh I, Kondaveeti U, Nargund G, Verso J. An Irish out-patient based in-vitro fertilisation service. Ir Med J. 1992 Jun;85(2):63-5.

    PMID: 1628945BACKGROUND

  • Gohar J, Lunenfeld E, Potashnik G, Glezerman M. The use of sedation only during oocyte retrieval for in vitro fertilization: patients' pain self-assessments versus doctors' evaluations. J Assist Reprod Genet. 1993 Oct;10(7):476-8. doi: 10.1007/BF01212936. No abstract available.

    PMID: 8069089BACKGROUND

  • Wikland M, Evers H, Jakobsson AH, Sandqvist U, Sjoblom P. The concentration of lidocaine in follicular fluid when used for paracervical block in a human IVF-ET programme. Hum Reprod. 1990 Nov;5(8):920-3. doi: 10.1093/oxfordjournals.humrep.a137220.

    PMID: 2081803BACKGROUND

  • Schnell VL, Sacco AG, Savoy-Moore RT, Ataya KM, Moghissi KS. Effects of oocyte exposure to local anesthetics on in vitro fertilization and embryo development in the mouse. Reprod Toxicol. 1992;6(4):323-7. doi: 10.1016/0890-6238(92)90195-y.

    PMID: 1521005BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

LidocaineSolutions

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPharmaceutical Preparations

Study Officials

  • Tarek Motan, MB ChB

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2013

First Posted

March 20, 2013

Study Start

March 1, 2013

Primary Completion

November 7, 2015

Study Completion

November 7, 2015

Last Updated

July 18, 2022

Record last verified: 2014-12

Locations

CA(1)