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

NCT ID: NCT01329302

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 257 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2016-06-30

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.

Conditions

Infertility, Female; Ovarian Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Group A: Direct aspiration

Group Type: ACTIVE_COMPARATOR

Direct aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen Aspiration

Intervention Type: PROCEDURE

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

Follicular Flushing

Group Type: ACTIVE_COMPARATOR

Direct aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen Aspiration

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Schiltigheim, Schiltigheim, France

Countries

France

References

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.

Reference Type: RESULT

PMID: 32200248 (View on PubMed)

Other Identifiers

2010-A00589-30

Identifier Type: -

Identifier Source: org_study_id