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Comparing Two Types of Needle for Oocytes Retrieval (NEEDLE)

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ClinicalTrials.gov Identifier: NCT03611907
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infertility, Female ART Device: Oocyte retrieval with only aspiration system "SL1(Cook® Single Lumen)" Device: Oocyte retrieval with aspiration and flushing system "DL1 (Cook® EchoTip® Double Lumen)" Not Applicable

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 among 2 double lumen and 2 single lumen needles commonly used in Humanitas' clinical practice in terms of:

Number of oocytes retrieved, oocyte recovery percentage per aspirated follicles, recovery time for single oocyte, percentage of Metaphase II (MII) oocytes retrieved.

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective randomized controlled clinical trial is designed to highlight differences between Double Lumen Aspiration Needle and Single Lumen Needle commonly used in clinical practice in terms of: Number of oocytes retrieved, oocyte recovery percentage per aspirated follicles, recovery time for single oocyte, percentage of MII oocytes retrieved
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trial Comparing Different Needles for Oocyte's Retrieval.
Actual Study Start Date : March 6, 2019
Actual Primary Completion Date : May 31, 2020
Actual Study Completion Date : January 20, 2021
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Oocyte retrieval percentage per aspirated follicles [ Time Frame: through study completion, 9 months ]
    Comparison between the oocyte retrieval percentage per aspirated follicles by 2 double lumen and 2 single lumen needles commonly used


Secondary Outcome Measures :
  1. Time for single oocyte retrieval (minutes) [ Time Frame: through study completion, 9 months ]
    comparison between the recovery time for single oocyte in days by 2 double lumen and 2 single lumen needles commonly used

  2. Percentage of MII oocytes retrieved [ Time Frame: through study completion, 9 months ]
    A comparison between the percentage of MII oocytes retrieved by 2 double lumen and 2 single lumen needles commonly used


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • IVF/ intracytoplasmatic sperm injection (ICSI) cycles;

Exclusion Criteria:

  • Ovarian Endometriomas;
  • Severe previous pelvic inflammatory disease with frozen pelvis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611907


Locations
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Italy
Paolo Emanuele Levi Setti
Rozzano, MI, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
More Information
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Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT03611907    
Other Study ID Numbers: 1965
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Infertility, Female