Clinical trial NCT01329302: Benefit of Follicular Flushing During Oocyte Retrieval for Poor Responder Patient in an Assisted Reproductive Technology Program
Official title: Follicular Flushing for Poor Responder Patient in an Assisted Reproductive Technology Program: Flush Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Ovarian Insufficiency
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2011-04-05
Enrollment: 257
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: the number of mature oocytes collected
timeFrame: 2 years and 9 months
measure: quality of embryos obtained
timeFrame: 2 years and 9 months
Secondary outcomes:
measure: Number of embryos obtained
timeFrame: 2 years and 9 months
measure: Number of transferable embryos (transferred and frozen)
timeFrame: 2 years and 9 months
measure: Number of pregnancies obtained
timeFrame: 2 years and 9 months
Other outcomes:
Locations:
city: Schiltigheim
country: France
facility: Centre d'Assistance Médicale à la Procréation, CMCO-SIHCUS
Study officials:
References: