Infertility, FemaleNCT01329302
Benefit of Follicular Flushing During Oocyte Retrieval for Poor Responder Patient in an Assisted Reproductive Technology Program
A study testing Direct aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen Aspiration in people with Infertility, Female and Ovarian Insufficiency, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The object of this study is to determine the benefit of follicular flushing with a double channel needle in a poor responder population for a maximum number of oocytes to be retrieved. The investigators compare two methods of oocyte retrieval with or without flushing. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Infertility, Female, Ovarian Insufficiency
- What is being tested?
- Direct aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen Aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Jun 2016
- 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 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients undergoing an IVF or ICSI treatment
- long agonist, antagonist or short stimulations protocols
- less than 5 follicles of 14mm or more day of HCG
- Major patients aged under 43 years
- patient within a couple married or can prove a married life of over 2 years
Who cannot join
- all the cons indication to the oocyte retrieval
- oocyte donor
- Couple supported viral loop
- Patient does not speak French or unable to give informed consent
- Patients major protected
- Patients with biopsy performed on weekends are also excluded due to unavailability of adequate personnel and equipment
- Absence of follicles
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Assistance Médicale à la Procréation, CMCO-SIHCUS
Schiltigheim, Schiltigheim, 67300
About this study
Official title: Follicular Flushing for Poor Responder Patient in an Assisted Reproductive Technology Program: Flush Study
The object of this study is to determine the benefit of follicular flushing with a double channel needle in a poor responder population for a maximum number of oocytes to be retrieved. The investigators compare two methods of oocyte retrieval with or without flushing. 220 patients undergoing an in vitro fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) have to be included. All patients with less than 5 follicles of 14 mm and more the day of ovulation induction will be included, following a randomized protocol in two groups, Group A: Oocyte retrieval is performed with a single lumen aspiration needle 17G. Group B: Oocyte retrieval is performed with a double lumen aspiration needle 17G. all follicles are flushed with flushing solution in addition to direct aspiration of the follicular fluid, 20CC of flushing medium is provided for all the procedure and flushing medium is collected separately from direct fluid aspiration in order to follow up each oocyte one by one. First criterion of our comparison is the number of oocyte retrieved. Second criteria are: oocyte quality, fertilization rate, number and quality of embryos obtained, clinical pregnancy rate. In Group B the investigators will compare two subgroups: oocytes collected in flush medium and oocytes from direct follicle fluid. Then the investigators will know the capability of oocyte collected after follicular flushing to be fertilized and to increase the success chance of pregnancy for poor responder patients.
- Conditions
- Infertility, Female, Ovarian Insufficiency
- Being tested
- Direct aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen Aspiration
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen AspirationProcedure or surgery
In addition to direct aspiration of the follicular fluid all follicles are flushed with flushing solution, 20CC of flushing medium( Flushing Medium MediCultâ France) is provided for all the procedure and flushing medium is collected separately from direct fluid
| Study group | Role | What they receive |
|---|---|---|
| Group A: Direct aspiration | Active comparator | Not described Receives: Procedure: Direct aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen Aspiration |
| Follicular Flushing | Active comparator | Not described Receives: Procedure: Direct aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen Aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of mature oocytes collected
Increase the number of mature oocytes collected during the follicular flushing with a double lumen aspiration needle
Measured: 2 years and 9 months
quality of embryos obtained
Embryo quality is assessed at the Laboratory of Reproductive Biology by a score based on: cell number, cell regularity and degree of fragmentation.
Measured: 2 years and 9 months
Secondary outcomes (3)
Number of embryos obtained
Measured: 2 years and 9 months
Number of transferable embryos (transferred and frozen)
Biologist at Day 3 chooses the best quality embryos for transfer and freeze the other if the quality is sufficient.
Measured: 2 years and 9 months
Number of pregnancies obtained
Measured: 2 years and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2016
- Study completionJun 2016
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 University Hospital, Strasbourg, FranceThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329302
- Sponsor's protocol ID
- 2010-A00589-30
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2010
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Calabre C, Schuller E, Goltzene MA, Rongieres C, Celebi C, Meyer N, Teletin M, Pirrello O. Follicular flushing versus direct aspiration in poor responder IVF patients: a randomized prospective study. Eur J Obstet Gynecol Reprod Biol. 2020 May;248:118-122. doi: 10.1016/j.ejogrb.2020.03.003. Epub 2020 Mar 6.
PubMed 32200248
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follicular Flushing for Poor Responder Patient in an Assisted Reproductive Technology Program: Flush Study
- ClinicalTrials.gov ID
- NCT01329302
- Acronym / sponsor ID
- 2010-A00589-30
- Conditions
- Infertility, Female, Ovarian Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 5 Apr 2011 (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 object of this study is to determine the benefit of follicular flushing with a double channel needle in a poor responder population for a maximum number of oocytes to be retrieved. The investigators compare two methods of oocyte retrieval with or without flushing. 220 patients undergoing an in vitro fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) have to be included. All patients with less than 5 follicles of 14 mm and more the day of ovulation induction will be included, following a randomized protocol in two groups, Group A: Oocyte retrieval is performed with a single lumen aspiration needle 17G. Group B: Oocyte retrieval is performed with a double lumen aspiration needle 17G. all follicles are flushed with flushing solution in addition to direct aspiration of the follicular fluid, 20CC of flushing medium is provided for all the procedure and flushing medium is collected separately from direct fluid aspiration in order to follow up each oocyte one by one. First criterion of our comparison is the number of oocyte retrieved. Second criteria are: oocyte quality, fertilization rate, number and quality of embryos obtained, clinical pregnancy rate. In Group B the investigators will compare two subgroups: oocytes collected in flush medium and oocytes from direct follicle fluid. Then the investigators will know the capability of oocyte collected after follicular flushing to be fertilized and to increase the success chance of pregnancy for poor responder patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Direct aspiration | Active comparator | Procedure: Direct aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen Aspiration |
| Follicular Flushing | Active comparator | Procedure: Direct aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen Aspiration |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- patients undergoing an IVF or ICSI treatment
- long agonist, antagonist or short stimulations protocols
- less than 5 follicles of 14mm or more day of HCG
- Major patients aged under 43 years
- patient within a couple married or can prove a married life of over 2 years
Key exclusion criteria (7 listed)
- all the cons indication to the oocyte retrieval
- oocyte donor
- Couple supported viral loop
- Patient does not speak French or unable to give informed consent
- Patients major protected
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 |
|---|---|---|
| Direct aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen AspirationIn addition to direct aspiration of the follicular fluid all follicles are flushed with flushing solution, 20CC of flushing medium( Flushing Medium MediCultâ France) is provided for all the procedure and flushing medium is collected separately from direct fluid | Procedure or surgery | Follicular Flushing, Group A: Direct aspiration |
Primary outcome
the number of mature oocytes collected
Time frame: 2 years and 9 months
Increase the number of mature oocytes collected during the follicular flushing with a double lumen aspiration needle
quality of embryos obtained
Time frame: 2 years and 9 months
Embryo quality is assessed at the Laboratory of Reproductive Biology by a score based on: cell number, cell regularity and degree of fragmentation.
3 secondary outcomes
Number of embryos obtained
Time frame: 2 years and 9 months
Number of transferable embryos (transferred and frozen)
Time frame: 2 years and 9 months
Number of pregnancies obtained
Time frame: 2 years and 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 16 Dec 2025.
- Results publication: PubMed 32200248Calabre C, Schuller E, Goltzene MA, Rongieres C, Celebi C, Meyer N, Teletin M, Pirrello O. Follicular flushing versus direct aspiration in poor responder IVF patients: a randomized prospective study. Eur J Obstet Gynecol Reprod Biol. 2020 May;248:118-122. doi: 10.1016/j.ejogrb.2020.03.003. Epub 2020 Mar 6.
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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 Direct aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen Aspiration in people with Infertility, Female and Ovarian Insufficiency, run by University Hospital, Strasbourg, France at 1 site in France.
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 5 inclusion and 7 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 16 Dec 2025. 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 France. 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?
the number of mature oocytes collected (time frame: 2 years and 9 months). The study lists 2 primary outcomes in all. 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 NCT01329302, 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 16 Dec 2025.