Infertility, Female Clinical Trial
— NEEDLEOfficial title:
Prospective Randomized Controlled Trial Comparing Different Needles for Oocyte's Retrieval.
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 |
Verified date | September 2022 |
Source | Istituto Clinico Humanitas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Paolo Emanuele Levi Setti | Rozzano | MI |
Lead Sponsor | Collaborator |
---|---|
Istituto Clinico Humanitas |
Italy,
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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