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

Primary Purpose

Infertility, Female, Ovarian Insufficiency

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Direct aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen Aspiration
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility, Female

Eligibility Criteria

18 Years - 43 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre d'Assistance Médicale à la Procréation, CMCO-SIHCUS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A: Direct aspiration

Follicular Flushing

Arm Description

Outcomes

Primary Outcome Measures

the number of mature oocytes collected
Increase the number of mature oocytes collected during the follicular flushing with a double lumen aspiration needle
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.

Secondary Outcome Measures

Number of embryos obtained
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.
Number of pregnancies obtained

Full Information

First Posted
December 22, 2010
Last Updated
October 29, 2020
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT01329302
Brief Title
Benefit of Follicular Flushing During Oocyte Retrieval for Poor Responder Patient in an Assisted Reproductive Technology Program
Official Title
Follicular Flushing for Poor Responder Patient in an Assisted Reproductive Technology Program: Flush Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 2011 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, Ovarian Insufficiency

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
257 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: Direct aspiration
Arm Type
Active Comparator
Arm Title
Follicular Flushing
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Direct aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen Aspiration
Intervention Description
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
Primary Outcome Measure Information:
Title
the number of mature oocytes collected
Description
Increase the number of mature oocytes collected during the follicular flushing with a double lumen aspiration needle
Time Frame
2 years and 9 months
Title
quality of embryos obtained
Description
Embryo quality is assessed at the Laboratory of Reproductive Biology by a score based on: cell number, cell regularity and degree of fragmentation.
Time Frame
2 years and 9 months
Secondary Outcome Measure Information:
Title
Number of embryos obtained
Time Frame
2 years and 9 months
Title
Number of transferable embryos (transferred and frozen)
Description
Biologist at Day 3 chooses the best quality embryos for transfer and freeze the other if the quality is sufficient.
Time Frame
2 years and 9 months
Title
Number of pregnancies obtained
Time Frame
2 years and 9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Centre d'Assistance Médicale à la Procréation, CMCO-SIHCUS
City
Schiltigheim
ZIP/Postal Code
67300
Country
France

12. IPD Sharing Statement

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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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