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Completed

NCT Number: NCT01329302

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

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.

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Key information

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Schiltigheim, 67300, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. the number of mature oocytes collected

    Time frame: 2 years and 9 months

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

  2. quality of embryos obtained

    Time frame: 2 years and 9 months

    Embryo quality is assessed at the Laboratory of Reproductive Biology by a score based on: cell number, cell regularity and degree of fragmentation.

Secondary outcomes

  1. Number of embryos obtained

    Time frame: 2 years and 9 months

  2. Number of transferable embryos (transferred and frozen)

    Time frame: 2 years and 9 months

    Biologist at Day 3 chooses the best quality embryos for transfer and freeze the other if the quality is sufficient.

  3. Number of pregnancies obtained

    Time frame: 2 years and 9 months

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Apr 5, 2011
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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