Clinical trial NCT03611907: Comparing Two Types of Needle for Oocytes Retrieval
Official title: Prospective Randomized Controlled Trial Comparing Different Needles for Oocyte's Retrieval.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
ART
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* IVF/ intracytoplasmatic sperm injection (ICSI) cycles;

Exclusion Criteria:

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

Primary outcomes:
measure: Number of retrieved oocytes per procedure
timeFrame: through study completion, 9 months
Secondary outcomes:
measure: Time for single oocyte retrieval (minutes)
timeFrame: through study completion, 9 months
measure: Percentage of MII oocytes retrieved
timeFrame: through study completion, 9 months
measure: Oocyte retrieval percentage per aspirated follicles
timeFrame: through study completion, 9 months
measure: number of punctured follicles
timeFrame: through study completion, 9 months
measure: number of follicles at the trigger day
timeFrame: through study completion, 9 months
measure: the number of retrieved oocytes/ number of follicles at the trigger day
timeFrame: through study completion, 9 months
measure: time of the single procedure
timeFrame: through study completion, 9 months
measure: Complication rate
timeFrame: through study completion, 9 months
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Paolo Emanuele Levi Setti
state: MI
Study officials:
References: