Comparing Two Types of Needle for Oocytes Retrieval

NCT ID: NCT03611907

Last Updated: 2022-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-06
• Study Completion Date: 2021-01-20

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.

Conditions

Infertility, Female; ART

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SL1(Cook® Single Lumen)

Oocyte retrieval with only aspiration system

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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

DL1 (Cook® EchoTip® Double Lumen)

Oocyte retrieval with aspiration and flushing system

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

Interventions

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

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• IVF/ intracytoplasmatic sperm injection (ICSI) cycles;

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Paolo Emanuele Levi Setti

Rozzano, MI, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 37069472 (View on PubMed)

Other Identifiers

1965

Identifier Type: -

Identifier Source: org_study_id