Infertility Clinical Trial
Official title:
Experience of Pain During Oocyte Retrieval- a Comparison Between Two Aspiration Needles
Verified date | January 2021 |
Source | Vitrolife |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Vitrolife |
Sweden,
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 |
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