Comparing Two Types of Needle for Oocytes Retrieval

NCT03611907 | Completed

• 1 other identifier: 1965
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female; ART

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Time for single oocyte retrieval (minutes)

  through study completion, 9 months

• Percentage of MII oocytes retrieved

  through study completion, 9 months

• Oocyte retrieval percentage per aspirated follicles

  through study completion, 9 months

• number of punctured follicles

  through study completion, 9 months

• number of follicles at the trigger day

  through study completion, 9 months

Study Arms (2)

SL1(Cook® Single Lumen)

ACTIVE COMPARATOR

Oocyte retrieval with only aspiration system

Device: Oocyte retrieval with only aspiration system "SL1(Cook® Single Lumen)"

DL1 (Cook® EchoTip® Double Lumen)

ACTIVE COMPARATOR

Oocyte retrieval with aspiration and flushing system

Device: Oocyte retrieval with aspiration and flushing system "DL1 (Cook® EchoTip® Double Lumen)"

Interventions

Oocyte retrieval with only aspiration system "SL1(Cook® Single Lumen)" DEVICE

In this intervention a 17-Gauge needle is used to aspirate the follicles

SL1(Cook® Single Lumen)

Oocyte retrieval with aspiration and flushing system "DL1 (Cook® EchoTip® Double Lumen)" DEVICE

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

DL1 (Cook® EchoTip® Double Lumen)

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• IVF/ intracytoplasmatic sperm injection (ICSI) cycles;

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Paolo Emanuele Levi Setti

Rozzano, MI, 20089, Italy

Location

Related Publications (1)

• Ronchetti C, Cirillo F, Immediata V, Gargasole C, Scolaro V, Morenghi E, Albani E, Patrizio P, Levi-Setti PE. A Monocentric Randomized Controlled Clinical Trial to Compare Single- and Double-Lumen Needles in Oocyte Retrieval Procedure in Assisted Reproductive Technologies. Reprod Sci. 2023 Sep;30(9):2866-2875. doi: 10.1007/s43032-023-01232-w. Epub 2023 Apr 17.

  PMID: 37069472 DERIVED

MeSH Terms

Conditions

Infertility, Female

Interventions

Oocyte Retrieval

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Tissue and Organ Harvesting; Transplantation; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective randomized controlled clinical trial is designed to highlight differences between Double Lumen Aspiration Needle and Single Lumen Needle commonly used in clinical practice primarly in terms of number of retrieved oocytes per procedure.

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: August 2, 2018
• Study Start: March 6, 2019
• Primary Completion: May 31, 2020
• Study Completion: January 20, 2021
• Last Updated: September 27, 2022

Record last verified: 2022-09

Locations

IT (1)