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

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Swemed Follicle Aspiration Set Reduced Single Lumen
Swemed Follicle Aspiration Set Single Lumen (1.4 mm)
Sponsored by
Vitrolife
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Reproductive Medicine, Fertilization in Vitro, Oocyte retrieval, Local anaesthesia, Aspiration needle

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • IVF-kliniken Falun
  • Fertilitetscentrum Göteborg
  • Reproduktionmedicinskt Center, Universitetssjukhuset MAS
  • Fertilitetsenheten K59 Karolinska Universitetssjukhuset, Huddinge

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thin Follicle Aspiration Needle

Standard Follicle Aspiration Needle

Arm Description

Transvaginal oocyte retrieval was performed under local anaesthesia and under guidance of ultrasound with the RN needle that had an outer diameter of 0.9 mm (20 gauge) and inner diameter of 0.6 mm for the last 50 mm from the tip of the needle and an outer diameter of 1.4 mm (17 gauge) and inner diameter of 1 mm for the remaining length of the needle. The puncture procedure was performed according to each clinic's standard routine. Aspiration pressure was kept at a negative pressure between 90 and 120 mmHg.

Transvaginal oocyte retrieval was performed under local anaesthesia and under guidance of ultrasound with the SN needle that had an outer diameter of 1.4 mm (17 gauge) and inner diameter of 1 mm for the remaining length of the needle. or the SN with an outer diameter of 1.4 mm (17 gauge) and inner diameter of 1 mm for the whole length of the needle. The puncture procedure was performed according to each clinic's standard routine. Aspiration pressure was kept at a negative pressure between 90 and 120 mmHg.

Outcomes

Primary Outcome Measures

Visual Analogue Scale
Rating of pain was performed by self-assessment by means of Visual Analogue Scale (VAS) consisting of a line oriented vertically on a paper with a range from 0 mm (no pain) to 100 mm (unbearable pain).

Secondary Outcome Measures

Intervention Because of Bleeding
Vaginal bleeding during or after the procedure was graded subjectively by the physician as (i) less than normal, (ii) normal or (iii) more than normal.

Full Information

First Posted
June 17, 2009
Last Updated
January 8, 2021
Sponsor
Vitrolife
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1. Study Identification

Unique Protocol Identification Number
NCT00924885
Brief Title
Experience of Pain During Oocyte Retrieval- a Comparison Between Two Aspiration Needles
Official Title
Experience of Pain During Oocyte Retrieval- a Comparison Between Two Aspiration Needles
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitrolife

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Reproductive Medicine, Fertilization in Vitro, Oocyte retrieval, Local anaesthesia, Aspiration needle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
257 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thin Follicle Aspiration Needle
Arm Type
Experimental
Arm Description
Transvaginal oocyte retrieval was performed under local anaesthesia and under guidance of ultrasound with the RN needle that had an outer diameter of 0.9 mm (20 gauge) and inner diameter of 0.6 mm for the last 50 mm from the tip of the needle and an outer diameter of 1.4 mm (17 gauge) and inner diameter of 1 mm for the remaining length of the needle. The puncture procedure was performed according to each clinic's standard routine. Aspiration pressure was kept at a negative pressure between 90 and 120 mmHg.
Arm Title
Standard Follicle Aspiration Needle
Arm Type
Active Comparator
Arm Description
Transvaginal oocyte retrieval was performed under local anaesthesia and under guidance of ultrasound with the SN needle that had an outer diameter of 1.4 mm (17 gauge) and inner diameter of 1 mm for the remaining length of the needle. or the SN with an outer diameter of 1.4 mm (17 gauge) and inner diameter of 1 mm for the whole length of the needle. The puncture procedure was performed according to each clinic's standard routine. Aspiration pressure was kept at a negative pressure between 90 and 120 mmHg.
Intervention Type
Device
Intervention Name(s)
Swemed Follicle Aspiration Set Reduced Single Lumen
Intervention Description
Thin tip to penetrate the tissue
Intervention Type
Device
Intervention Name(s)
Swemed Follicle Aspiration Set Single Lumen (1.4 mm)
Intervention Description
Standard (1.4 mm) needle to penetrate the tissue
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Rating of pain was performed by self-assessment by means of Visual Analogue Scale (VAS) consisting of a line oriented vertically on a paper with a range from 0 mm (no pain) to 100 mm (unbearable pain).
Time Frame
After the oocyte retrieval and before the patient leaves the operation room e.g. within a maximum of 30 minutes.
Secondary Outcome Measure Information:
Title
Intervention Because of Bleeding
Description
Vaginal bleeding during or after the procedure was graded subjectively by the physician as (i) less than normal, (ii) normal or (iii) more than normal.
Time Frame
During and directly after oocyte retrieval

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torbjörn Hillensjö, MD PhD
Organizational Affiliation
Fertility Center Scandinavia
Official's Role
Principal Investigator
Facility Information:
Facility Name
IVF-kliniken Falun
City
Falun
ZIP/Postal Code
79182
Country
Sweden
Facility Name
Fertilitetscentrum Göteborg
City
Göteborg
ZIP/Postal Code
40229
Country
Sweden
Facility Name
Reproduktionmedicinskt Center, Universitetssjukhuset MAS
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Fertilitetsenheten K59 Karolinska Universitetssjukhuset, Huddinge
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
21467200
Citation
Wikland M, Blad S, Bungum L, Hillensjo T, Karlstrom 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.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/21467200
Description
Link to the published article

Learn more about this trial

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

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