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

NCT00924885 | Completed Results

• 1 other identifier: Vitrolife-needle-01
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 4

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.

Conditions

Infertility

Keywords

Reproductive Medicine; Fertilization in Vitro; Oocyte retrieval; Local anaesthesia; Aspiration needle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Intervention Because of Bleeding

  During and directly after oocyte retrieval

Study Arms (2)

Thin Follicle Aspiration Needle

EXPERIMENTAL

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

Standard Follicle Aspiration Needle

ACTIVE COMPARATOR

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)

Interventions

Swemed Follicle Aspiration Set Reduced Single Lumen DEVICE

Thin tip to penetrate the tissue

Thin Follicle Aspiration Needle

Swemed Follicle Aspiration Set Single Lumen (1.4 mm) DEVICE

Standard (1.4 mm) needle to penetrate the tissue

Standard Follicle Aspiration Needle

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The patient has previously participated in Vitrolife-needle-01 study
• The patient has a body mass index ≥35
• Other contra indicator for oocyte retrieval

Sponsors & Collaborators

• Vitrolife: lead

Study Sites (4)

IVF-kliniken Falun

Falun, 79182, Sweden

Location

Fertilitetscentrum Göteborg

Gothenburg, 40229, Sweden

Location

Reproduktionmedicinskt Center, Universitetssjukhuset MAS

Malmo, 205 02, Sweden

Location

Fertilitetsenheten K59 Karolinska Universitetssjukhuset, Huddinge

Stockholm, 141 86, Sweden

Location

Related Publications (1)

• 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.

  PMID: 21467200 DERIVED

Related Links

• Link to the published article

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Results Point of Contact

• Title: Director of clinical investigations
• Organization: Vitrolife

thardarson@vitrolife.com

0046708228063

Study Officials

• Torbjörn Hillensjö, MD PhD

  Fertility Center Scandinavia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 19, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 26, 2021
• Results First Posted: December 10, 2020

Record last verified: 2021-01

Locations

SE (4)