Impact of Local Biopsy to the Endometrium Prior to Controlled Ovarian Stimulation on Clinical Pregnancy
Condition: Primary or Secondary Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      In vitro fertilization (IVF) is the only available solution for many couples with various
      forms of infertility. The embryo implantation step in the IVF procedure is a complex
      multistage process and represents the majority of the causes of the IVF failure. Several
      approaches have been evaluated to improve implantation rates but none has demonstrated its
      superiority. However, endometrial receptivity is important for pregnancy and several studies
      suggest that local injury to the endometrium of IVF patients improves the rates of embryo
      implantation, clinical pregnancy and live birth.
    

Detailed description: 
      They are possible mechanisms by which endometrial sampling may increase receptivity and
      improve clinical pregnancy rate of IVF-ET. First, local injury to proliferative phase
      endometrium might induce the decidualization of the endometrium, and increase its
      implantation rate. Second, local injury to the endometrium might provoke the wound healing,
      involving a mass secretion of different cytokines and growth factor, which are beneficial for
      embryo implantation. Last, the injury might make the endometrium maturation.

      This study proposes to evaluate the efficiency of an endometrial injury in the first
      controlled ovarian hyperstimulation cycle on the rate of clinical pregnancy, in assisted
      reproductive technologies. This study will compare 2 groups of patients. The first group will
      undergo biopsy of the endometrium before the IVF; the second will undergo the IVF alone.
      Inclusions will be conducted on 33 months; the patients will be in the study for a period of
      36 weeks. The total duration of the study is 39 months
    

Intervention name(s): biopsy; IVF
Intervention type(s): Procedure; Procedure
Intervention description(s): The endometrium biopsy will be done as the same time as the GnRH treatment. The biopsy is realised with a Pipette de Cornier® (CDD international, PROMIDED France) following the laboratory protocol:
Apply antiseptic solution (povidone-iodine, Dakin®) on the cervix and vagina. In most cases, using Pozzi forceps is not necessary.
Insert carefully the pipelle de Cornier® in the uterus through the cervix.
Withdraw the piston to create a negative pression
Move the pipelle de cornier® in and out while twisting. Take care to no remove the pipelle form the uterus (suction lost). Twist the pipelle de Cornier® to cover an angle of 360°. Make several "in and out" cycle in order to collect a complete sample of the endometrium.
Withdraw the pipelle de Cornier® when filled with tissue
Reinsert internal piston to deposit sample in cup filled with a fixative.; fresh IVF-embryo transfer treated with long protocol for the controlled ovarian hyperstimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: In Vitro Fertilization; biopsy; pregnancy; Implantation; Embryo; first or second IVF tentative