Comparing Two Types of Needle for Oocytes Retrieval

Not Applicable

Completed

• Conditions: Infertility, Female; ART
• Interventions: Device: Oocyte retrieval with only aspiration system "SL1(Cook® Single Lumen)"; Device: Oocyte retrieval with aspiration and flushing system "DL1 (Cook® EchoTip® Double Lumen)"

• Registration Number: NCT03611907
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

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.

Detailed Description

After a long period in which Humanitas department used double lumen needles for oocytes retrieval in the last four years the choice of the needle is an operator choice, usually influenced by the number of follicles present at human Chorionic Gonadotropin (hCG) trigger.

This prospective randomized controlled clinical trial is designed to highlight differences between Double Lumen Aspiration Needle and Single Lumen Needle commonly used in Humanitas' clinical practice primarly in terms of number of retrived oocytes per procedure (A). Secondary outcomes are the number of punctured follicles (B), the retrieval rate (%) (A/B), the number of follicles at the last ultrasound performed prior to the ovulation trigger (C), the number of retrieved oocytes / number of follicles at trigger-day (A/C), retrieval procedure time (D), single oocyte retrieval time (D/A), the number of mature oocytes (and MII) and complications rate. Number of transferred embryos, number of frozen embryos and oocytes, clinical pregnancy rate per retrieval and per transfer (considering the number of pregnancies diagnosed by US visualization of one or more gestational sacs or definitive clinical signs of pregnancy per 100 cycles) and total number of clinical pregnancies with fetal heart beat (confirmed by visualization of one or more embryos with heartbeat at early dating ultrasound), are also evaluated. Standard protocols will be used for controlled ovarian hyper stimulation. Trans vaginal ultrasound-guided oocyte retrieval will be performed 36 hours ± 2 after hCG injection with the patient under deep sedation.

One hundred patients per each needle will be enrolled in this trial.

Study Timeline

• Study First Submitted: 2018-06-26
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-08-02
• Study Start: 2019-03-06
• Primary Completion: 2020-05-31
• Study Completion: 2021-01-20
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-24
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• IVF/ intracytoplasmatic sperm injection (ICSI) cycles;

Exclusion Criteria

• Ovarian Endometriomas;
• Severe previous pelvic inflammatory disease with frozen pelvis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of retrieved oocytes per procedure	through study completion, 9 months	Comparison of the number of retrieved oocytes per procedure among the two arms

Secondary Outcome Measures

Name	Time	Method
Oocyte retrieval percentage per aspirated follicles	through study completion, 9 months	Comparison between the oocyte retrieval percentage per aspirated follicles among the two arms
the number of retrieved oocytes/ number of follicles at the trigger day	through study completion, 9 months	Comparison of the number of retrieved oocytes/ number of follicles at the trigger day among the two arms
Percentage of MII oocytes retrieved	through study completion, 9 months	A comparison between the percentage of MII oocytes retrieved among the two arms
number of punctured follicles	through study completion, 9 months	Comparison of the number of punctured follicles among the two arms
Complication rate	through study completion, 9 months	Comparison of the complication rate among the two arms
time of the single procedure	through study completion, 9 months	Comparison of the time of the single procedure among the two arms
Time for single oocyte retrieval (minutes)	through study completion, 9 months	comparison between the recovery time for single oocyte in days among the two arms
number of follicles at the trigger day	through study completion, 9 months	Comparison of the number of follicles at the trigger day among the two arms

Trial Locations

Locations (1)

Paolo Emanuele Levi Setti; 🇮🇹 Rozzano, MI, Italy