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

Follicular Flushing for Poor Responder Patient in an Assisted Reproductive Technology Program: Flush 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.

Study Overview

• Status: Completed
• Conditions: Infertility, Female; Ovarian Insufficiency
• Intervention / Treatment: 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
• Enrollment (Actual): 257
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Schiltigheim
    • Schiltigheim, Schiltigheim, France, 67300
      • Centre d'Assistance Médicale à la Procréation, CMCO-SIHCUS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Publications and helpful links

General Publications

• Calabre C, Schuller E, Goltzene MA, Rongieres C, Celebi C, Meyer N, Teletin M, Pirrello O. Follicular flushing versus direct aspiration in poor responder IVF patients: a randomized prospective study. Eur J Obstet Gynecol Reprod Biol. 2020 May;248:118-122. doi: 10.1016/j.ejogrb.2020.03.003. Epub 2020 Mar 6.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2011
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: December 22, 2010
• First Submitted That Met QC Criteria: April 1, 2011
• First Posted (Estimated): April 5, 2011

Study Record Updates

• Last Update Posted (Estimated): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Infertility; Infertility, Female
• Other Study ID Numbers: 2010-A00589-30