Comparing Two Types of Needle for Oocytes Retrieval

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility, Female, ART

Intervention / Treatment
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* Device: Oocyte retrieval with only aspiration system SL1(Cook® Single Lumen)
* Device: Oocyte retrieval with aspiration and flushing system DL1 (Cook® EchoTip® Double Lumen)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IVF/ intracytoplasmatic sperm injection (ICSI) cycles; Exclusion Criteria: Ovarian Endometriomas; Severe previous pelvic inflammatory disease with frozen pelvis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SL1(Cook® Single Lumen)<br>Oocyte retrieval with only aspiration system | Device: Oocyte retrieval with only aspiration system SL1(Cook® Single Lumen)<br>* In this intervention a 17-Gauge needle is used to aspirate the follicles<br>|
| Active Comparator: DL1 (Cook® EchoTip® Double Lumen)<br>Oocyte retrieval with aspiration and flushing system | Device: Oocyte retrieval with aspiration and flushing system DL1 (Cook® EchoTip® Double Lumen)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Percentage of MII oocytes retrieved | A comparison between the percentage of MII oocytes retrieved among the two arms | through study completion, 9 months | 
| Oocyte retrieval percentage per aspirated follicles | Comparison between the oocyte retrieval percentage per aspirated follicles among the two arms | through study completion, 9 months | 
| number of punctured follicles | Comparison of the number of punctured follicles among the two arms | through study completion, 9 months | 
| 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 | 
| 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 | 
| time of the single procedure | Comparison of the time of the single procedure among the two arms | through study completion, 9 months | 
| Complication rate | Comparison of the complication rate among the two arms | through study completion, 9 months |