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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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Brief 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. 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 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 Design
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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
Arms and Interventions
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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
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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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 :
  1. Number of embryos obtained [ Time Frame: 2 years and 9 months ]
  2. 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.

  3. Number of pregnancies obtained [ Time Frame: 2 years and 9 months ]

Eligibility Criteria
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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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Information from the National Library of Medicine

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


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
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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