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

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ClinicalTrials.gov Identifier: NCT00924885
Recruitment Status : Completed
First Posted : June 19, 2009
Last Update Posted : October 29, 2013
Sponsor:
Information provided by (Responsible Party):
Vitrolife

Brief Summary:
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 or disease Intervention/treatment Phase
Infertility Device: Swemed Follicle Aspiration Set Reduced Single Lumen Device: Swemed Follicle Aspiration Set Single Lumen (1.4 mm) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Experience of Pain During Oocyte Retrieval- a Comparison Between Two Aspiration Needles
Study Start Date : June 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: After the oocyte retrieval and before the patient leaves the operation room ]

Secondary Outcome Measures :
  1. Intervention because of bleeding [ Time Frame: 2 hours after the oocyte retrieval ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vitrolife
ClinicalTrials.gov Identifier: NCT00924885     History of Changes
Other Study ID Numbers: Vitrolife-needle-01
First Posted: June 19, 2009    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: October 2013

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