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

Vitrolife

Status: Completed

Conditions: Infertility

Treatments: Device: Swemed Follicle Aspiration Set Reduced Single Lumen; Device: Swemed Follicle Aspiration Set Single Lumen (1.4 mm)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00924885

Vitrolife-needle-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 257 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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257 participants in 2 patient groups

Thin Follicle Aspiration Needle

Experimental group

Description:

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.

Treatment:

Device: Swemed Follicle Aspiration Set Reduced Single Lumen

Standard Follicle Aspiration Needle

Active Comparator group

Description:

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.

Treatment:

Device: Swemed Follicle Aspiration Set Single Lumen (1.4 mm)