Comparing Two Types of Needle for Oocytes Retrieval
Condition: Infertility, Female; ART
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

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.
    

Intervention name(s): Oocyte retrieval with only aspiration system "SL1(Cook® Single Lumen)"; Oocyte retrieval with aspiration and flushing system "DL1 (Cook® EchoTip® Double Lumen)"
Intervention type(s): Device; Device
Intervention description(s): In this intervention a 17-Gauge needle is used to aspirate the follicles; 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
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 primarly in terms of number of retrieved oocytes per procedure.
Masking: None (Open Label)
Primary purpose: Treatment