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

Not Applicable

Completed

• Conditions: Infertility, Female; Ovarian Insufficiency

• Registration Number: NCT01329302
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-22
• Study Start: 2011-03
• Study First Submitted QC: 2011-04-01
• Study First Posted: 2011-04-05
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-29
• Last Update Posted: 2020-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 257

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the number of mature oocytes collected	2 years and 9 months	Increase the number of mature oocytes collected during the follicular flushing with a double lumen aspiration needle
quality of embryos obtained	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 Outcome Measures

Name	Time	Method
Number of transferable embryos (transferred and frozen)	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.
Number of pregnancies obtained	2 years and 9 months
Number of embryos obtained	2 years and 9 months

Trial Locations

Locations (1)

Centre d'Assistance Médicale à la Procréation, CMCO-SIHCUS; 🇫🇷 Schiltigheim, France