NCT03611907: NEEDLE

Comparing Two Types of Needle for Oocytes Retrieval

Completed NA Last updated 27 September 2022

What this trial tests

NA trial testing Oocyte retrieval with only aspiration system "SL1(Cook® Single Lumen)" in Infertility, Female in 200 participants. Completed in 20 January 2021.

Timeline

6 March 2019

Primary endpoint
31 May 2020

20 January 2021

Quick facts

Lead sponsor	Istituto Clinico Humanitas
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	6 March 2019
Primary completion	31 May 2020
Estimated completion	20 January 2021
Sites	1 location across Italy

Drugs / interventions tested

• Oocyte retrieval with only aspiration system "SL1(Cook® Single Lumen)"
• Oocyte retrieval with aspiration and flushing system "DL1 (Cook® EchoTip® Double Lumen)"

Conditions studied

• Infertility, Female — all drugs for Infertility, Female →
• ART — all drugs for ART →

Sponsor

Istituto Clinico Humanitas

Who can join

Adults 18 to 42, female only, with Infertility, Female or ART. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In the early stages of assisted reproductive technologies (ART), oocyte retrieval was performed via laparoscopy, a cumbersome and expensive process requiring general anesthesia. Today, transvaginal oocyte retrieval for ART is a routine procedure performed under ultrasound guidance. Double-lumen retrieval needles, which are capable of flushing ovarian follicles, were developed to overcome the possibility of oocyte retention within the ovarian follicles and retrieval collection system. Single lumen needles have been introduced and are routinely used by most groups due to their supposed ability to retrieve the same number of oocytes in a shorter operation time.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Monocentric Randomized Controlled Clinical Trial to Compare Single- and Double-Lumen Needles in Oocyte Retrieval Procedure in Assisted Reproductive Technologies.
   Ronchetti C, Cirillo F, Immediata V, Gargasole C, et al · · 2023 · cited 3× · PMID 37069472 · DOI 10.1007/s43032-023-01232-w
2. A systematic review and meta-analysis of randomized controlled studies comparing follicular flushing versus aspiration during oocyte retrieval in IVF cycles.
   El-Goly NA, Maged AM, Essam A, Shoab A. · · 2025 · cited 1× · PMID 40165322 · DOI 10.1186/s40834-025-00351-w