Infertility, FemaleNEEDLENCT03611907
Comparing Two Types of Needle for Oocytes Retrieval
A study testing Oocyte retrieval with only aspiration system "SL1(Cook® Single Lumen)" and Oocyte retrieval with aspiration and flushing system "DL1 (Cook® EchoTip® Double Lumen)" in people with Infertility, Female and ART, run by Istituto Clinico Humanitas at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility, Female, ART
- What is being tested?
- Oocyte retrieval with only aspiration system "SL1(Cook® Single Lumen)" and Oocyte retrieval with aspiration and flushing system "DL1 (Cook® EchoTip® Double Lumen)"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 6 Mar 2019to 20 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- IVF/ intracytoplasmatic sperm injection (ICSI) cycles;
Who cannot join
- Ovarian Endometriomas;
- Severe previous pelvic inflammatory disease with frozen pelvis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Controlled Trial Comparing Different Needles for Oocyte's Retrieval.
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.
Read the 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.
- Conditions
- Infertility, Female, ART
- Being tested
- Oocyte retrieval with only aspiration system "SL1(Cook® Single Lumen)", Oocyte retrieval with aspiration and flushing system "DL1 (Cook® EchoTip® Double Lumen)"
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oocyte retrieval with only aspiration system "SL1(Cook® Single Lumen)"Device
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)"Device
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
| Study group | Role | What they receive |
|---|---|---|
| SL1(Cook® Single Lumen) | Active comparator | Oocyte retrieval with only aspiration system Receives: Device: Oocyte retrieval with only aspiration system "SL1(Cook® Single Lumen)" |
| DL1 (Cook® EchoTip® Double Lumen) | Active comparator | Oocyte retrieval with aspiration and flushing system Receives: Device: Oocyte retrieval with aspiration and flushing system "DL1 (Cook® EchoTip® Double Lumen)" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of retrieved oocytes per procedure
Comparison of the number of retrieved oocytes per procedure among the two arms
Measured: through study completion, 9 months
Secondary outcomes (8)
Time for single oocyte retrieval (minutes)
comparison between the recovery time for single oocyte in days among the two arms
Measured: through study completion, 9 months
Percentage of MII oocytes retrieved
A comparison between the percentage of MII oocytes retrieved among the two arms
Measured: through study completion, 9 months
Oocyte retrieval percentage per aspirated follicles
Comparison between the oocyte retrieval percentage per aspirated follicles among the two arms
Measured: through study completion, 9 months
number of punctured follicles
Comparison of the number of punctured follicles among the two arms
Measured: 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
Measured: 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
Measured: through study completion, 9 months
time of the single procedure
Comparison of the time of the single procedure among the two arms
Measured: through study completion, 9 months
Complication rate
Comparison of the complication rate among the two arms
Measured: through study completion, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start6 Mar 2019
- Primary completion31 May 2020
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611907
- Sponsor's protocol ID
- 1965
- Acronym
- NEEDLE
- Status last verified
- Sep 2022
- First submitted
- 26 Jun 2018
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ronchetti C, Cirillo F, Immediata V, Gargasole C, Scolaro V, Morenghi E, Albani E, Patrizio P, Levi-Setti PE. A Monocentric Randomized Controlled Clinical Trial to Compare Single- and Double-Lumen Needles in Oocyte Retrieval Procedure in Assisted Reproductive Technologies. Reprod Sci. 2023 Sep;30(9):2866-2875. doi: 10.1007/s43032-023-01232-w. Epub 2023 Apr 17.
PubMed 37069472
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial Comparing Different Needles for Oocyte's Retrieval.
- ClinicalTrials.gov ID
- NCT03611907
- Acronym / sponsor ID
- NEEDLE / 1965
- Conditions
- Infertility, Female, ART
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SL1(Cook® Single Lumen) | Active comparator | Device: Oocyte retrieval with only aspiration system "SL1(Cook® Single Lumen)"Oocyte retrieval with only aspiration system |
| DL1 (Cook® EchoTip® Double Lumen) | Active comparator | Device: Oocyte retrieval with aspiration and flushing system "DL1 (Cook® EchoTip® Double Lumen)"Oocyte retrieval with aspiration and flushing system |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- IVF/ intracytoplasmatic sperm injection (ICSI) cycles;
Key exclusion criteria (2 listed)
- Ovarian Endometriomas;
- Severe previous pelvic inflammatory disease with frozen pelvis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oocyte retrieval with only aspiration system "SL1(Cook® Single Lumen)"In this intervention a 17-Gauge needle is used to aspirate the follicles | Device | SL1(Cook® Single Lumen) |
| 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 | Device | DL1 (Cook® EchoTip® Double Lumen) |
Primary outcome
Number of retrieved oocytes per procedure
Time frame: through study completion, 9 months
Comparison of the number of retrieved oocytes per procedure among the two arms
8 secondary outcomes
Time for single oocyte retrieval (minutes)
Time frame: through study completion, 9 months
Percentage of MII oocytes retrieved
Time frame: through study completion, 9 months
Oocyte retrieval percentage per aspirated follicles
Time frame: through study completion, 9 months
number of punctured follicles
Time frame: through study completion, 9 months
number of follicles at the trigger day
Time frame: through study completion, 9 months
the number of retrieved oocytes/ number of follicles at the trigger day
Time frame: through study completion, 9 months
time of the single procedure
Time frame: through study completion, 9 months
Complication rate
Time frame: through study completion, 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Derived from this study: PubMed 37069472Ronchetti C, Cirillo F, Immediata V, Gargasole C, Scolaro V, Morenghi E, Albani E, Patrizio P, Levi-Setti PE. A Monocentric Randomized Controlled Clinical Trial to Compare Single- and Double-Lumen Needles in Oocyte Retrieval Procedure in Assisted Reproductive Technologies. Reprod Sci. 2023 Sep;30(9):2866-2875. doi: 10.1007/s43032-023-01232-w. Epub 2023 Apr 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oocyte retrieval with only aspiration system "SL1(Cook® Single Lumen)" and Oocyte retrieval with aspiration and flushing system "DL1 (Cook® EchoTip® Double Lumen)" in people with Infertility, Female and ART, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of retrieved oocytes per procedure (time frame: through study completion, 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03611907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.