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

Infertility, Female research study

What is the primary objective of this 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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Infertility, Female

Ovarian Insufficiency

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure: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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Group A: Direct aspiration

Follicular Flushing

Study Status

Unknown status

Start Date: March 2011

Completed Date: November 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: the number of mature oocytes collected

Secondary Outcome: Number of embryos obtained

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: University Hospital, Strasbourg, France

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01329302

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