Prospective Study of an Human Endometrial Receptivity Test
Condition: Infertile
MeSH terms: Infertility
Study type: Observational

Summary: 
      Evaluation of endometrial receptivity is a crucial step in in vitro
      fertilization/intracytoplasmic sperm injection (IVF/ICSI) programs. Using "Omic
      technologies", such as transcriptomic and proteomic analyses, the investigators previously
      identified a specific molecular signature of human endometrial receptivity during the embryo
      implantation window. After validation of this signature in fertile women and in an ex vivo
      model (i.e., stromal and epithelial endometrium cells),the investigatorsdeveloped a
      diagnostic tool called Win-Test (Window Implantation Test) to evaluate the expression level
      of a set of endometrial receptivity-specific genes during the implantation window by
      quantitative RT-PCR. Based on their expression, each endometrial biopsy sample can be
      classified as receptive, partially receptive or non-receptive. Then, after the identification
      of the right cycle day within the implantation window where endometrium is considered as
      receptive, a customized timing for embryo transfer with respect of the synchronization of the
      embryo-maternal dialogue must be performed. A prospective study to validate the relevance of
      the Win-Test, is a necessary step to gauge its effectiveness. In this objective, patients
      with multiple implantation failures will be recruited. Embryo transfers were performed in
      double-arm: the intervention group had a customized timing of embryo transfer according to
      the Win-Test strategy and recommendation, the control group had their embryos transferred in
      a classical timing. Pregnancy and live birth rates (LBR) were compared between groups.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women were recruited after written informed consent. All of them had a severe history of
        repeated implantation failures (RIFs). A classical infertility evaluation was performed
        including transvaginal sonography and uterine cavity was assessed by hysteroscopy. All
        patients were scheduled for replacement of cryopreserved embryos under hormone replacement
        therapy (HRT) or natural cycle. A mock frozen embryo transfer cycle, using a natural cycle
        or a HRT protocol, was monitored. Patients had endometrial biopsies performed through the
        presumed implantation window, 6 to 9 days after the LH (luteinizing hormone) surge for
        those on natural cycle or 5 to 9 days after the progesterone administration under HRT. Each
        biopsy was assessed for endometrial receptivity status using the Win-Test and assessment
        was stopped when appropriate endometrial receptivity was found. The clinical suitability of
        the Win-Test was performed in RIF patients who subsequently received Win-Test's guided
        embryo transfer.
      
Keywords: Endometrial receptivity assessment for customized embryo transfer; Human Reproduction; ART; Endometrial receptivity