Comparing Two Types of Needle for Oocytes Retrieval (NEEDLE)

Prospective Randomized Controlled Trial Comparing Different Needles for Oocyte's Retrieval.

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • Rozzano, MI, Italy, 20089
      • Paolo Emanuele Levi Setti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• IVF/ intracytoplasmatic sperm injection (ICSI) cycles;

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SL1(Cook® Single Lumen); Oocyte retrieval with only aspiration system	Device: Oocyte retrieval with only aspiration system "SL1(Cook® Single Lumen)"; In this intervention a 17-Gauge needle is used to aspirate the follicles
Active Comparator: DL1 (Cook® EchoTip® Double Lumen); Oocyte retrieval with aspiration and flushing system	Device: Oocyte retrieval with aspiration and flushing system "DL1 (Cook® EchoTip® Double Lumen)"; In this intervention a 17-Gauge needle is used to aspirate follicle, and consequently a 1 mL flush is injected and aspirated twice for each punctured follicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of retrieved oocytes per procedure	Comparison of the number of retrieved oocytes per procedure among the two arms	through study completion, 9 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2019
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 24, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: 1965

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No