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

Study Overview
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Brief Summary
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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.

Official Title
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Follicular Flushing for Poor Responder Patient in an Assisted Reproductive Technology Program: Flush Study

Conditions
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Infertility, Female, Ovarian Insufficiency

Intervention / Treatment
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* Procedure: Direct aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen Aspiration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A: Direct aspiration<br> | Procedure: Direct aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen Aspiration<br>* 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<br>|
| Active Comparator: Follicular Flushing<br> | Procedure: Direct aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen Aspiration<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of mature oocytes collected | Increase the number of mature oocytes collected during the follicular flushing with a double lumen aspiration needle | 2 years and 9 months | 
| quality of embryos obtained | Embryo quality is assessed at the Laboratory of Reproductive Biology by a score based on: cell number, cell regularity and degree of fragmentation. | 2 years and 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of embryos obtained |  | 2 years and 9 months | 
| Number of transferable embryos (transferred and frozen) | Biologist at Day 3 chooses the best quality embryos for transfer and freeze the other if the quality is sufficient. | 2 years and 9 months | 
| Number of pregnancies obtained |  | 2 years and 9 months |