Repetitive Implantation Failure Clinical Trial
Official title:
The Endometrial Receptivity Array (ERA) as Diagnosis and Personalized Embryo Transfer (pET) as Treatment in Patients With Receptive Implantation Failure (RIF).
The purpose of this study is to demonstrate the clinical efficiency of the Endometrial Receptivity Array (ERA) diagnostic tool in patients with repetitive implantation failure (RIF), leading to the new concept of the personalized window of implantation (pWOI) as diagnostic and treatment of patients with RIF of endometrial origin.
Intervention(s): Endometrial sampling, either at LH+7 in a natural cycle or after 5 days of
progesterone in a hormonal replacement cycle (HRT) and personalized embryo transfer (pET) on
the designated day guided by the ERA prediction.
Repeated implantation failure (RIF) is an unsolved not well characterized major cause of
infertility in otherwise healthy women. Although various definitions of RIF exist, the
clinical community agrees that after failure of three IVF cycles, in which one to two
morphologically high-grade embryos have been transferred, special protocols must be
enforced, although no hard data from RCTs demonstrates that any of the current approaches in
RIF have a significant clinical value .
Based on the large amount of information generated about the regulation and deregulation of
the genes implicated in the endometrial window of receptivity (WOR), our group has developed
a molecular diagnostic tool based on the specific transcriptomic signature that identifies
the receptive endometrium at LH+7 in a natural cycle or on day 5 of progesterone
impregnation (P+5) after proper estradiol priming in a hormonal replacement therapy (HRT)
cycle. The endometrial receptivity array (ERA) consists of a customized array containing 238
genes differentially expressed that is coupled to a computational predictor able to diagnose
the personalized endometrial WOI of a given patient, regardless of its histological
appearance. The accuracy of the diagnostic tool ERA has been demonstrated to be superior to
endometrial histology and results are completely reproducible 29 to 40 months later.
Compelling evidence indicates the existence of an endometrial receptivity alteration in
patients with RIF.
The aim of this study is to demonstrate the diagnostic efficiency of the ERA test in RIF
patients by identifying putative alterations related to the displacement of their
personalized window of receptivity, and the therapeutic implications through personalization
of the day of embryo transfer (pET), following the diagnosis obtained by this molecular
diagnostic tool. An endometrial biopsy on day LH+7 in a natural cycle or on day P+5 in an
HRT cycle and ERA diagnosis of receptive or non-receptive is informed. In receptive cases,
embryo transfer (ET) will be performed in subsequent cycles on the indicated day. In
non-receptive ERA, the test is to be repeated on the dayindicated by the predictor, and
personalized ET guided in subsequent cycles according to ERA diagnosis.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic