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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Device: Swemed Follicle Aspiration Set Reduced Single Lumen; Device: Swemed Follicle Aspiration Set Single Lumen (1.4 mm)

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
• Enrollment (Actual): 257
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Falun, Sweden, 79182
    • IVF-kliniken Falun
  • Göteborg, Sweden, 40229
    • Fertilitetscentrum Göteborg
  • Malmö, Sweden, 205 02
    • Reproduktionmedicinskt Center, Universitetssjukhuset MAS
  • Stockholm, Sweden, 141 86
    • Fertilitetsenheten K59 Karolinska Universitetssjukhuset, Huddinge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Thin Follicle Aspiration Needle; 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.	Device: Swemed Follicle Aspiration Set Reduced Single Lumen; Thin tip to penetrate the tissue
ACTIVE_COMPARATOR: Standard Follicle Aspiration Needle; 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.	Device: Swemed Follicle Aspiration Set Single Lumen (1.4 mm); Standard (1.4 mm) needle to penetrate the tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	After the oocyte retrieval and before the patient leaves the operation room e.g. within a maximum of 30 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During and directly after oocyte retrieval

Collaborators and Investigators

• Sponsor: Vitrolife
• Investigators: Principal Investigator: Torbjörn Hillensjö, MD PhD, Fertility Center Scandinavia

Publications and helpful links

General Publications

• 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.

Helpful Links

• Link to the published article

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: June 17, 2009
• First Submitted That Met QC Criteria: June 18, 2009
• First Posted (ESTIMATE): June 19, 2009

Study Record Updates

• Last Update Posted (ACTUAL): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 8, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Reproductive Medicine; Fertilization in Vitro; Local anaesthesia; Oocyte retrieval; Aspiration needle
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: Vitrolife-needle-01