Infertilityneedles(opu)NCT02391155
Follicular Flushing Outcomes in Singles Versus Double Lumen Oocyte Retrieval Needles in Poor Responding Patients
A study testing single lumen needle in oocyte retrieval and double lumen needle in oocyte retrieval in people with Infertility, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators aimed to evaluate to the efficacy of the needle type used in follicular flushing in oocyte retrieval in the poorest responders undergoing IVF. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- single lumen needle in oocyte retrieval and double lumen needle in oocyte retrieval
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2015to Jul 2015
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women between 20-45 years old
- the number of follicles less than 5 on the day of HCG administration
- the value of progesteron on the day of hCG administration must be under 1.5ng/ml
Who cannot join
- women under 20 years and older than 45 year
- on the day of hCG administration if the follicle number is more than 5
- if.the value of progesteron on the day of hCG administration is higher than 1.5ng/ml
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follicular Flushing Outcomes in Singles Versus Double Lumen Oocyte Retrieval Needles in Poor Responding Patients:a Randomized Controlled Trial
In this study, the investigators aimed to evaluate to the efficacy of the needle type used in follicular flushing in oocyte retrieval in the poorest responders undergoing IVF.
Read the detailed description
This study will include:
- women with less than four follicles on the day of hCG administration
- women between 20-45 age old
- The value of progesterone on the day of hCG administration will be under 1.5ng/ml
- Conditions
- Infertility
- Being tested
- single lumen needle in oocyte retrieval, double lumen needle in oocyte retrieval
- Keywords
- follicular flushing, IVF, poor responders, oocyte retrival
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single lumen needle in oocyte retrievalProcedure or surgery
single lumen needle use during oocyte retrieval
double lumen needle in oocyte retrievalProcedure or surgery
after aspiration of follicles, 3 times flushing will be performed in double lumen needle.
| Study group | Role | What they receive |
|---|---|---|
| single lumen | Active comparator | Single lumen needle in oocyte retrieval Receives: Procedure: single lumen needle in oocyte retrieval; Procedure: double lumen needle in oocyte retrieval |
| double lumen | Active comparator | Double lumen needle with follicle flushing during oocyte retrieval Receives: Procedure: single lumen needle in oocyte retrieval; Procedure: double lumen needle in oocyte retrieval |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of metaphase 2 oocyte
Measured: Six months
Secondary outcomes (1)
clinical pregnancy rate
Measured: eigth months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bulent Haydardedeoglu, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391155
- Sponsor's protocol ID
- KA13/161
- Acronym
- needles(opu)
- Status last verified
- Mar 2015
- First submitted
- 11 Feb 2015
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follicular Flushing Outcomes in Singles Versus Double Lumen Oocyte Retrieval Needles in Poor Responding Patients:a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02391155
- Acronym / sponsor ID
- needles(opu) / KA13/161
- Conditions
- Infertility
- Keywords
- follicular flushing, IVF, poor responders, oocyte retrival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 18 Mar 2015 (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.
In this study, the investigators aimed to evaluate to the efficacy of the needle type used in follicular flushing in oocyte retrieval in the poorest responders undergoing IVF.
Detailed description
This study will include:
- women with less than four follicles on the day of hCG administration
- women between 20-45 age old
- The value of progesterone on the day of hCG administration will be under 1.5ng/ml
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single lumen | Active comparator | Procedure: single lumen needle in oocyte retrieval, Procedure: double lumen needle in oocyte retrievalSingle lumen needle in oocyte retrieval |
| double lumen | Active comparator | Procedure: single lumen needle in oocyte retrieval, Procedure: double lumen needle in oocyte retrievalDouble lumen needle with follicle flushing during oocyte retrieval |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women between 20-45 years old
- the number of follicles less than 5 on the day of HCG administration
- the value of progesteron on the day of hCG administration must be under 1.5ng/ml
Key exclusion criteria (3 listed)
- women under 20 years and older than 45 year
- on the day of hCG administration if the follicle number is more than 5
- if.the value of progesteron on the day of hCG administration is higher than 1.5ng/ml
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 in oocyte retrievalsingle lumen needle use during oocyte retrieval | Procedure or surgery | double lumen, single lumen |
| double lumen needle in oocyte retrievalafter aspiration of follicles, 3 times flushing will be performed in double lumen needle. | Procedure or surgery | double lumen, single lumen |
Primary outcome
number of metaphase 2 oocyte
Time frame: Six months
1 secondary outcome
clinical pregnancy rate
Time frame: eigth 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 2 Jul 2018.
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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 in oocyte retrieval and double lumen needle in oocyte retrieval in people with Infertility, 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 3 inclusion and 3 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 2 Jul 2018. 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?
number of metaphase 2 oocyte (time frame: Six months). 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 2 Jul 2018.