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Benefit of Follicular Flushing During Oocyte Retrieval for Poor Responder Patient in an Assisted Reproductive Technology Program
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by University Hospital, Strasbourg, France.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
University Hospital, Strasbourg, France
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01329302
First received: December 22, 2010
Last updated: September 29, 2015
Last verified: September 2015
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Purpose
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.
| Condition | Intervention |
|---|---|
| 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 |
| Study Type: | Interventional |
| Study Design: | 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 |
Further study details as provided by University Hospital, Strasbourg, France:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 260 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 43 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01329302
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329302
Contacts
| Contact: PIRRELLO Olivier, MD | 03 69 55 34 51 | olivier.pirrello@chru-strasbourg.fr |
Locations
| 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 | |
Sponsors and Collaborators
University Hospital, Strasbourg, France
More Information
| Responsible Party: | University Hospital, Strasbourg, France |
| ClinicalTrials.gov Identifier: | NCT01329302 History of Changes |
| Other Study ID Numbers: |
2010-A00589-30 |
| Study First Received: | December 22, 2010 |
| Last Updated: | September 29, 2015 |
Additional relevant MeSH terms:
|
Infertility Flushing Infertility, Female |
Genital Diseases, Male Genital Diseases, Female Signs and Symptoms |
ClinicalTrials.gov processed this record on September 19, 2017