A prospective, randomized, controlled, open two-arm study to evaluate the interest of the pre-conceptional endometrial immune profiling to increase birth rates.
Birth rates following an embryo transfer with a mean of two embryos transferred stagnate around 23% per transfer (annual report of the Agency of Biomedicine). Some estimates that half of infertile patients treated are partially or totally concerned by problem of inadequate uterine receptivity. The investigators' hypothesis is that a pre-conceptional immune endometrial evaluation may increase significantly birth rates since successful implantation results from both the matching of a competent embryo within a competent endometrium. The identification of endometrial biomarkers documenting the immune uterine environment during the implantation window would be able to improve the efficacy of ART through a personalization of treatment accordingly to the ability of the patients to receive their embryos. All patients with all inclusion criteria and no exclusion criteria will be included. Only patients with a deregulation (immune analysis) will be randomized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
No specific medical care
Regarding the immune endometrial profiling, medical care (personalization of treatment) should follow a step by step decision tree.
Hôpital Saint-Louis - Laboratoire MatriceLAb Innove
Paris, France
Live birth rate (without congenital abnormality or malformation)/transfer following the first (fresh) embryo transfer after uterine immune analysis
Live birth rate/transfer
Time frame: up to 18 months
Ongoing pregnancy rate/transfer following the first embryo transfer at 12 weeks of amenorrhea
Ongoing pregnancy rate/transfer following the first embryo transfer
Time frame: 12 amenorrhea weeks
Number of physiological pregnancies after personalization
Physiological pregnancies are defined by a normal growth of the fetus and a birth at term.
Time frame: up to 18 months
Pregnancy rate/transfer following the first embryo transfer
Pregnancy rate/transfer following the first embryo transfer
Time frame: 8 amenorrhea weeks
Number of embryo implanted/number of embryos replaced)
Implantation rate
Time frame: at 8, 12 and 40 amenorrhea weeks
Number of early miscarriage in the first trimester
Number of early miscarriage in the first trimester
Time frame: 12 amenorrhea weeks
Number of late miscarriage
Number of late miscarriage
Time frame: between 13 and 24 amenorrhea weeks
Term of birth (for babies without congenital anormality or malformation)
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Term of birth
Time frame: up to 18 months
Weight at birth
A weight of birth below the 10 percentile according to the table of reference with distribution of birth weight in function of the term of birth in the overall population define the intrauterine growth retardation (for babies without congenital anormality or malformation)
Time frame: up to 18 months
Number of prematurity (A birth below 37 weeks of amenorrhea defines the premature birth and before 28 weeks of amenorrhea the severe preterm birth) (for babies without congenital anormality or malformation)
Number of prematurity (A birth below 37 weeks of amenorrhea)
Time frame: between 28 and 37 amenorrhea weeks
Number of pre-eclampsia (defined as the association of hypertension over 14/9 mm of hg with proteinuria occuring during the pregnancy- this pathology is related to insufiscient invasion during the first trimester)
Number of pre-eclampsia (defined as the association of hypertension over 14/9 mm of hg with proteinuria occuring during the pregnancy- this pathology is related to insufiscient invasion during the first trimester)
Time frame: up to 18 months
Number of pathologic pregnancy included stillbirth and congenital abnormality
Number of pathologic pregnancy included stillbirth and congenital abnormality
Time frame: up to 18 months
Investigate if immunologic events studying on endometrial level have an impact on blood level or are independent.
Quantification by flow cytometry of circulating NK cells (CD56 +/CD16 -), T regulatory T cells (FoxP3) with study of the repretory of circulating and uterine NK receptors (NPp46, Nkp30, NKp44).
Time frame: up to 15 months