InfertilityNCT02749773
Is There a Difference in Oocyte Quality? A Comparison of Two Aspiration Needle Gauges
A study testing Oocyte Aspiration needle in people with Infertility, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to determine whether different needle gauges influences the quality of the aspirated oocytes during in-vivo fertilization (IVF). Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Oocyte Aspiration needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- May 2016to May 2017
- 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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fertility treatment
- Antral follicle count
Who cannot join
- Women who refuse to participate
Trial locations and contacts
1 site in 1 country.
Yuval Atzmon, MD contact
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Yuval Atzmon, MD, atzmony@gmail.com
About this study
The aim of this study is to determine whether different needle gauges influences the quality of the aspirated oocytes during in-vivo fertilization (IVF).
- Conditions
- Infertility
- Being tested
- Oocyte Aspiration needle
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oocyte Aspiration needleDevice
Oocyte aspiration in women go through an IVF procedure,.
| Study group | Role | What they receive |
|---|---|---|
| Oocyte aspiration with 17G needle | Active comparator | Oocyte Aspiration with 17G needle. Receives: Device: Oocyte Aspiration needle |
| Oocyte aspiration with (20-17G) needle | Active comparator | Oocyte Aspiration (20-17G) needle. Receives: Device: Oocyte Aspiration needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oocyte Quality microscopic description.
Aspirated oocytes from both needle gauges will be compared for quality according to 5 parameters: Polar body, Zona pellucida, Dark cytoplasm, Perivitelline space and Vacuoles.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
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 InfertilityStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yuval Atzmon, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749773
- Sponsor's protocol ID
- HYMC-0026-16
- Status last verified
- May 2016
- First submitted
- 6 Apr 2016
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Atzmon Y, Michaeli M, Aslih N, Ruzov O, Rotfarb N, Shoshan-Karchovsky E, Shalom-Paz E. Degenerative Oocytes in the Aspirated Cohort Are Not Due to the Aspirating Needle: a Prospective Randomized Pilot Study with Sibling Oocytes. Reprod Sci. 2021 Jul;28(7):1882-1889. doi: 10.1007/s43032-020-00384-3. Epub 2020 Nov 10.
PubMed 33171516
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Difference in Oocyte Quality? A Comparison of Two Aspiration Needle Gauges
- ClinicalTrials.gov ID
- NCT02749773
- Acronym / sponsor ID
- HYMC-0026-16
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- May 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 25 Apr 2016 (estimated)
- 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.
The aim of this study is to determine whether different needle gauges influences the quality of the aspirated oocytes during in-vivo fertilization (IVF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oocyte aspiration with 17G needle | Active comparator | Device: Oocyte Aspiration needleOocyte Aspiration with 17G needle. |
| Oocyte aspiration with (20-17G) needle | Active comparator | Device: Oocyte Aspiration needleOocyte Aspiration (20-17G) needle. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Fertility treatment
- Antral follicle count
Key exclusion criteria (1 listed)
- Women who refuse to participate
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 Aspiration needleOocyte aspiration in women go through an IVF procedure,. | Device | Oocyte aspiration with (20-17G) needle, Oocyte aspiration with 17G needle |
Primary outcome
Oocyte Quality microscopic description.
Time frame: One year
Aspirated oocytes from both needle gauges will be compared for quality according to 5 parameters: Polar body, Zona pellucida, Dark cytoplasm, Perivitelline space and Vacuoles.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
- Derived from this study: PubMed 33171516Atzmon Y, Michaeli M, Aslih N, Ruzov O, Rotfarb N, Shoshan-Karchovsky E, Shalom-Paz E. Degenerative Oocytes in the Aspirated Cohort Are Not Due to the Aspirating Needle: a Prospective Randomized Pilot Study with Sibling Oocytes. Reprod Sci. 2021 Jul;28(7):1882-1889. doi: 10.1007/s43032-020-00384-3. Epub 2020 Nov 10.
- Individual participant dataSharing planned: No
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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.
Yuval Atzmon, MD contact
Yuval Atzmon, MD principal investigator
Hillel Yaffe Medical Center
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 Aspiration needle in people with Infertility, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 May 2016. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuval Atzmon, MD (atzmony@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oocyte Quality microscopic description. (time frame: One year). 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 NCT02749773, 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 3 May 2016.