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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03611907
Other study ID # 1965
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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