Clinical Trials Directory

Trials / Completed

CompletedNCT01329302

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
257 (actual)
Sponsor
University Hospital, Strasbourg, France · Academic / Other
Sex
Female
Age
18 Years – 43 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREDirect aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen AspirationIn 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

Timeline

Start date
2011-03-01
Primary completion
2016-06-01
Completion
2016-06-01
First posted
2011-04-05
Last updated
2025-12-16

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01329302. Inclusion in this directory is not an endorsement.