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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01329302
• Other study ID #: 2010-A00589-30
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: June 2016

Study information

• Verified date: October 2020
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Flushing
• Infertility
• Infertility, Female
• Ovarian Insufficiency

Intervention

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

Locations

Country	Name	City	State
France	Centre d'Assistance Médicale à la Procréation, CMCO-SIHCUS	Schiltigheim

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of embryos obtained		2 years and 9 months
Secondary	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
Secondary	Number of pregnancies obtained		2 years and 9 months