Oocyte RetrievalNCT00995280
Single Lumen Needle Without Flushing or Double Lumen Needle With Follicle Flushing in Oocyte Retrieval
A study testing single lumen needle oocyte retrieval and double lumen needle oocyte retrieval in people with Oocyte Retrieval, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare whether oocyte flushing during retrieval is effective or not. Read more about this study
- Who is it for?
- Ages 20 to 41 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oocyte Retrieval
- What is being tested?
- single lumen needle oocyte retrieval and double lumen needle oocyte retrieval
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2008to Nov 2008
- 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 20 to 41 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients undergoing IVF/ICSI cycles.
Who cannot join
- Poor responder patients who have lower than 6 follicles at hCG administration day.
- Patients having over 30 follicles.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare whether oocyte flushing during retrieval is effective or not.
Read the detailed description
In total 300 patients will be randomized for the effectiveness of single or double lumen needle during oocyte retrieval. Double lumen needles give an opportunity of washing to the follicle with flush. Single lumen needles seem to be faster and no need for flushing. We aim to compare to the differences of the use of both needles.
- Conditions
- Oocyte Retrieval
- Being tested
- single lumen needle oocyte retrieval, double lumen needle oocyte retrieval
- Keywords
- follicle flushing, oocyte retrieval, needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single lumen needle oocyte retrievalDevice
single lumen needle use during oocyte retrieval
double lumen needle oocyte retrievalDevice
double lumen needle with 1 time follicle flushing with at least 2 ml during oocyte retrieval
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Single lumen needle use in oocyte retrieval Receives: Device: single lumen needle oocyte retrieval |
| 2 | Active comparator | Double lumen needle with follicle flushing during oocyte retrieval Receives: Device: double lumen needle oocyte retrieval |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metaphase 2 oocyte number
Measured: 6months
Secondary outcomes (1)
clinical pregnancy rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study startMar 2008
- Primary completionSep 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oocyte RetrievalStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995280
- Sponsor's protocol ID
- BHTB-03241705
- Status last verified
- Oct 2009
- First submitted
- 14 Oct 2009
- Last updated
- 15 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Lumen Needle Without Flushing or Double Lumen Needle With Follicle Flushing in Oocyte Retrieval
- ClinicalTrials.gov ID
- NCT00995280
- Acronym / sponsor ID
- BHTB-03241705
- Conditions
- Oocyte Retrieval
- Keywords
- follicle flushing, oocyte retrieval, needle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 15 Oct 2009 (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 compare whether oocyte flushing during retrieval is effective or not.
Detailed description
In total 300 patients will be randomized for the effectiveness of single or double lumen needle during oocyte retrieval. Double lumen needles give an opportunity of washing to the follicle with flush. Single lumen needles seem to be faster and no need for flushing. We aim to compare to the differences of the use of both needles.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: single lumen needle oocyte retrievalSingle lumen needle use in oocyte retrieval |
| 2 | Active comparator | Device: double lumen needle oocyte retrievalDouble lumen needle with follicle flushing during oocyte retrieval |
Who may qualify
- Ages
- 20 to 41 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients undergoing IVF/ICSI cycles.
Key exclusion criteria (2 listed)
- Poor responder patients who have lower than 6 follicles at hCG administration day.
- Patients having over 30 follicles.
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 |
|---|---|---|
| single lumen needle oocyte retrievalsingle lumen needle use during oocyte retrieval | Device | 1 |
| double lumen needle oocyte retrievaldouble lumen needle with 1 time follicle flushing with at least 2 ml during oocyte retrieval | Device | 2 |
Primary outcome
Metaphase 2 oocyte number
Time frame: 6months
1 secondary outcome
clinical pregnancy rate
Time frame: 6 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 15 Oct 2009.
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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 single lumen needle oocyte retrieval and double lumen needle oocyte retrieval in people with Oocyte Retrieval, run by Baskent University at 1 site in Turkey (Türkiye).
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 15 Oct 2009. 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 Turkey (Türkiye). 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?
Metaphase 2 oocyte number (time frame: 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2009.