Comparing Two Types of Needle for Oocytes Retrieval

Infertility, Female Clinical Trial

— NEEDLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611907
• Other study ID #: 1965
• Status: Completed
• Phase: N/A
• Start date: March 6, 2019
• Est. completion date: January 20, 2021

Study information

• Verified date: September 2022
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 20, 2021
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

• IVF/ intracytoplasmatic sperm injection (ICSI) cycles;

Exclusion Criteria:

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

Related Conditions & MeSH terms

• ART
• Infertility
• Infertility, Female

Intervention

Device:
• Oocyte retrieval with only aspiration system "SL1(Cook® Single Lumen)"
In this intervention a 17-Gauge needle is used to aspirate the follicles
• 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

Locations

Country	Name	City	State
Italy	Paolo Emanuele Levi Setti	Rozzano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Percentage of MII oocytes retrieved	A comparison between the percentage of MII oocytes retrieved among the two arms	through study completion, 9 months
Secondary	Oocyte retrieval percentage per aspirated follicles	Comparison between the oocyte retrieval percentage per aspirated follicles among the two arms	through study completion, 9 months
Secondary	number of punctured follicles	Comparison of the number of punctured follicles among the two arms	through study completion, 9 months
Secondary	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
Secondary	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
Secondary	time of the single procedure	Comparison of the time of the single procedure among the two arms	through study completion, 9 months
Secondary	Complication rate	Comparison of the complication rate among the two arms	through study completion, 9 months