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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00924885
• Other study ID #: Vitrolife-needle-01
• Status: Completed
• Phase: N/A
• Start date: June 2009
• Est. completion date: December 2009

Study information

• Verified date: January 2021
• Source: Vitrolife
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• Swemed Follicle Aspiration Set Reduced Single Lumen
Thin tip to penetrate the tissue
• Swemed Follicle Aspiration Set Single Lumen (1.4 mm)
Standard (1.4 mm) needle to penetrate the tissue

Locations

Country	Name	City	State
Sweden	IVF-kliniken Falun	Falun
Sweden	Fertilitetscentrum Göteborg	Göteborg
Sweden	Reproduktionmedicinskt Center, Universitetssjukhuset MAS	Malmö
Sweden	Fertilitetsenheten K59 Karolinska Universitetssjukhuset, Huddinge	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Vitrolife

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Link to the published article