Benefit of Follicular Flushing During Oocyte Retrieval for Poor Responder Patient in an Assisted Reproductive Technology Program
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ClinicalTrials.gov Identifier: NCT01329302 |
Recruitment Status
: Unknown
Verified September 2015 by University Hospital, Strasbourg, France.
Recruitment status was: Recruiting
First Posted
: April 5, 2011
Last Update Posted
: September 30, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infertility, Female Ovarian Insufficiency | Procedure: Direct aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen Aspiration | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 260 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Care Provider) |
Official Title: | Follicular Flushing for Poor Responder Patient in an Assisted Reproductive Technology Program: Flush Study |
Study Start Date : | March 2011 |
Estimated Primary Completion Date : | November 2015 |
Estimated Study Completion Date : | November 2015 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Group A: Direct aspiration |
Procedure: Direct aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen Aspiration
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
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Active Comparator: Follicular Flushing |
Procedure: Direct aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen Aspiration
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
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- 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.
- 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 ]Biologist at Day 3 chooses the best quality embryos for transfer and freeze the other if the quality is sufficient.
- Number of pregnancies obtained [ Time Frame: 2 years and 9 months ]

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Ages Eligible for Study: | 18 Years to 43 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329302
Contact: PIRRELLO Olivier, MD | 03 69 55 34 51 | olivier.pirrello@chru-strasbourg.fr |
France | |
Centre d'Assistance Médicale à la Procréation, CMCO-SIHCUS | Recruiting |
Schiltigheim, France, 67300 | |
Contact: PIRRELLO Olivier, MD 03 69 55 34 51 olivier.pirrello@chru-strasbourg.fr | |
Principal Investigator: PIRRELLO Olivier, MD | |
Sub-Investigator: FALLER Emilie, MD | |
Sub-Investigator: OHL Jeanine, MD | |
Sub-Investigator: RONGIERES Catherine, MD | |
Sub-Investigator: BETTAHAR Karima, MD | |
Sub-Investigator: MOREAU Laurence, MD | |
Sub-Investigator: FEGER Brigitte, MD | |
Sub-Investigator: SPIZZO Michèle, MD | |
Sub-Investigator: PLUMERE Claude, MD |
Responsible Party: | University Hospital, Strasbourg, France |
ClinicalTrials.gov Identifier: | NCT01329302 History of Changes |
Other Study ID Numbers: |
2010-A00589-30 |
First Posted: | April 5, 2011 Key Record Dates |
Last Update Posted: | September 30, 2015 |
Last Verified: | September 2015 |
Additional relevant MeSH terms:
Infertility Flushing Infertility, Female |
Genital Diseases, Male Genital Diseases, Female Signs and Symptoms |