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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Device: Swemed Follicle Aspiration Set Reduced Single Lumen
* Device: Swemed Follicle Aspiration Set Single Lumen (1.4 mm)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thin Follicle Aspiration Needle<br>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<br>* Thin tip to penetrate the tissue<br>|
| Active Comparator: Standard Follicle Aspiration Needle<br>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)<br>* Standard (1.4 mm) needle to penetrate the tissue<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reproductive Medicine, Fertilization in Vitro, Oocyte retrieval, Local anaesthesia, Aspiration needle