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

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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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IVF-kliniken Falun, Falun, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Swemed Follicle Aspiration Set Reduced Single Lumen

Device

Thin tip to penetrate the tissue

Swemed Follicle Aspiration Set Single Lumen (1.4 mm)

Device

Standard (1.4 mm) needle to penetrate the tissue

Primary outcomes

Visual Analogue Scale

Time frame: After the oocyte retrieval and before the patient leaves the operation room e.g. within a maximum of 30 minutes.

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).

Secondary outcomes

Intervention Because of Bleeding

Time frame: During and directly after oocyte retrieval

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.

Sponsors and collaborators

Lead sponsor

Vitrolife

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Jun 19, 2009
Registry last updated: Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed