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

This study has been completed.
Sponsor:
Information provided by:
Vitrolife
ClinicalTrials.gov Identifier:
NCT00924885
First received: June 17, 2009
Last updated: May 11, 2011
Last verified: December 2009
History of Changes
  Purpose

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.


Condition Intervention
Infertility
 Device: Swemed Follicle Aspiration Set Reduced Single Lumen
Device: Swemed Follicle Aspiration Set Single Lumen (1.4 mm)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Experience of Pain During Oocyte Retrieval- a Comparison Between Two Aspiration Needles

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Vitrolife:

Primary Outcome Measures:
  • Visual Analogue Scale [ Time Frame: After the oocyte retrieval and before the patient leaves the operation room ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intervention because of bleeding [ Time Frame: 2 hours after the oocyte retrieval ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: June 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thin Follicle Aspiration Needle Device: Swemed Follicle Aspiration Set Reduced Single Lumen
Thin tip to penetrate the tissue
Active Comparator: Standard Follicle Aspiration Needle Device: Swemed Follicle Aspiration Set Single Lumen (1.4 mm)
Standard (1.4 mm) needle to penetrate the tissue

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924885

Locations
Sweden
IVF-kliniken Falun
Falun, Sweden, 79182
Fertilitetscentrum Göteborg
Göteborg, Sweden, 40229
Reproduktionmedicinskt Center, Universitetssjukhuset MAS
Malmö, Sweden, 205 02
Fertilitetsenheten K59 Karolinska Universitetssjukhuset, Huddinge
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Vitrolife
Investigators
Principal Investigator: Torbjörn Hillensjö, MD PhD Fertility Center Scandinavia
  More Information

Additional Information:
Link to the published article  This link exits the ClinicalTrials.gov site

No publications provided by Vitrolife

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sofia Blad, Vitrolife Sweden AB
ClinicalTrials.gov Identifier: NCT00924885     History of Changes
Other Study ID Numbers: Vitrolife-needle-01
Study First Received: June 17, 2009
Last Updated: May 11, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by Vitrolife:
Reproductive Medicine
Fertilization in Vitro
Oocyte retrieval
Local anaesthesia
Aspiration needle

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 16, 2013