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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

257 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-12-31

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.

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Swemed Follicle Aspiration Set Reduced Single Lumen

Intervention Type DEVICE

Thin tip to penetrate the tissue

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.

Group Type ACTIVE_COMPARATOR

Swemed Follicle Aspiration Set Single Lumen (1.4 mm)

Intervention Type DEVICE

Standard (1.4 mm) needle to penetrate the tissue

Interventions

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Swemed Follicle Aspiration Set Reduced Single Lumen

Thin tip to penetrate the tissue

Intervention Type DEVICE

Swemed Follicle Aspiration Set Single Lumen (1.4 mm)

Standard (1.4 mm) needle to penetrate the tissue

Intervention Type DEVICE

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No