Comparing Two Types of Needle for Oocytes Retrieval (NEEDLE)

Istituto Clinico Humanitas

Status: Completed

Conditions: ART; Infertility, Female

Treatments: Device: Oocyte retrieval with only aspiration system "SL1(Cook® Single Lumen)"; Device: Oocyte retrieval with aspiration and flushing system "DL1 (Cook® EchoTip® Double Lumen)"

Study type: Interventional

Funder types: Other

Identifiers

NCT03611907

1965

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• IVF/ intracytoplasmatic sperm injection (ICSI) cycles;

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

SL1(Cook® Single Lumen)

Active Comparator group

Description:

Oocyte retrieval with only aspiration system

Treatment:

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

DL1 (Cook® EchoTip® Double Lumen)

Active Comparator group

Description:

Oocyte retrieval with aspiration and flushing system

Treatment:

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