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Benefit of Follicular Flushing During Oocyte Retrieval for Poor Responder Patient in an Assisted Reproductive Technology Program

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01329302
First received: December 22, 2010
Last updated: September 25, 2013
Last verified: September 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Official Title: Follicular Flushing for Poor Responder Patient in an Assisted Reproductive Technology Program: Flush Study

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Number of transferable embryos (transferred and frozen) [ Time Frame: 2 years and 9 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
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
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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 25, 2013
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Infertility, Female
Menopause, Premature
Primary Ovarian Insufficiency
Adnexal Diseases
Endocrine System Diseases
 Genital Diseases, Female
Gonadal Disorders
Infertility
Ovarian Diseases

ClinicalTrials.gov processed this record on February 27, 2015