Experience of Pain During Oocyte Retrieval- a Comparison Between Two Aspiration Needles

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vitrolife
ClinicalTrials.gov Identifier:
NCT00924885
First received: June 17, 2009
Last updated: October 28, 2013
Last verified: October 2013

June 17, 2009
October 28, 2013
June 2009
December 2009   (final data collection date for primary outcome measure)
Visual Analogue Scale [ Time Frame: After the oocyte retrieval and before the patient leaves the operation room ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00924885 on ClinicalTrials.gov Archive Site
Intervention because of bleeding [ Time Frame: 2 hours after the oocyte retrieval ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Experience of Pain During Oocyte Retrieval- a Comparison Between Two Aspiration Needles
Experience of Pain During Oocyte Retrieval- a Comparison Between Two Aspiration Needles

The purpose of the study is to compare the pain experience between the patients that have had their transvaginal oocytes retrieval with ultrasound guidance performed with reduced single lumen needle (Vitrolife Sweden AB, Gothenburg) with the patients that have had follicle aspiration needle, 1.4 outer diameter (Vitrolife Sweden AB, Gothenburg), during the procedure.

Although the patient is sedated and local analgesia has been given, transvaginal oocytes retrieval with ultrasound guidance can still cause a lot of pain, both during and after the procedure. To reduce the pain, some clinics prefer to use needles as thin as 0.8 mm (outer diameter, OD). A disadvantage with these needles is the increased aspiration time. Therefore a new needle has been developed that has the possibility to reduce pain without a large increase in aspiration time. The needle has a 50 mm long tip with an outer diameter of 0.9 mm. The remaining part of the needle is 300 mm long with an outer diameter of 1.4 mm.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Infertility
  • Device: Swemed Follicle Aspiration Set Reduced Single Lumen
    Thin tip to penetrate the tissue
  • Device: Swemed Follicle Aspiration Set Single Lumen (1.4 mm)
    Standard (1.4 mm) needle to penetrate the tissue
  • Experimental: Thin Follicle Aspiration Needle
    Intervention: Device: Swemed Follicle Aspiration Set Reduced Single Lumen
  • Active Comparator: Standard Follicle Aspiration Needle
    Intervention: Device: Swemed Follicle Aspiration Set Single Lumen (1.4 mm)
Wikland M, Blad S, Bungum L, Hillensjö T, Karlström PO, Nilsson S. A randomized controlled study comparing pain experience between a newly designed needle with a thin tip and a standard needle for oocyte aspiration. Hum Reprod. 2011 Jun;26(6):1377-83. doi: 10.1093/humrep/der100. Epub 2011 Apr 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The patient has signed an informed consent form before the oocyte retrieval
  • The patient is undergoing oocyte retrieval with local anaesthesia
  • The patient can speak and understand Swedish

Exclusion Criteria:

  • The patient has previously participated in Vitrolife-needle-01 study
  • The patient has a body mass index ≥35
  • Other contra indicator for oocyte retrieval
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00924885
Vitrolife-needle-01
No
Vitrolife
Vitrolife
Not Provided
Principal Investigator: Torbjörn Hillensjö, MD PhD Fertility Center Scandinavia
Vitrolife
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP