Thin Endometrium Clinical Trial
Official title:
Intrauterine Infusion of Autologous Platelet-Rich Plasma (PRP) in Women With Thin Endometrium Undergoing Embryo-transfer.
The goal of this interventional study is to evaluate the increasing in endometrial thickening after the intrauterine infusion of 0,5-1 ml of autologous Platelet-Rich Plasma (PRP) and the implantation rate in women with thin endometrium undergoing Embryo-transfer, in order to propose a novel therapeutic approach for women with an endometrium < 7 mm unresponsive to standard treatments.
In clinical practice, a thin endometrium, unresponsive to conventional therapies, usually
results in cycle cancellation and embryo cryopreservation. The evaluation of an adequate
endometrial growth is performed using grey-scale ultrasound. The minimal endometrial
thickness required for embryo transfer is now considered about 7 mm at the end of natural or
medically induced follicular phase, despite some investigators reported different cutoff
values, ranging between 7 and 10 mm. Currently, no evidence-based data show the predictive
positive value of endometrial thickness on pregnancy rate after Embryo-transfer, but if the
endometrial lining is below 7mm the chance of pregnancy is statistically significant reduced.
Thin endometrium is relatively frequent in women with previous trauma of the uterus (cesarean
sections, repetitive curettage), patients subjected to antitumoral treatments in childhood
(Radiotherapy, Chemotherapy, Surgery), women affected by Asherman's syndrome, chronic
infections (endometritis, Pelvic Inflammatory Disease) and inadequate blood flow (stress,
malposition of uterus, fibrosis), patients with low estradiol values or excessive use of
Clomiphene Citrate.
Several alternative treatments have been proposed over the years to improve the endometrial
thickening, then showed themselves to be not considered the answer in many cases: some of
them, indeed, require a not damaged endometrium, other act on endometrial blood flow and have
no direct proliferative effect on the endometrium. The only factor presumed to have a
proliferative effect on endometrium is the Granulocyte-Colony Stimulating Factor (G-CSF) but
this hypothesis is not supported by in vitro studies.
Recently, first results from an in vitro study ongoing on the evaluation of Platelet-Rich
Plasma (PRP) effect on endometrial cell proliferation have been presented (Aghayanova et al.,
2016). The authors demonstrated that PRP increased proliferation not only on cultured
fibroblasts, as currently known but also on mesenchymal cells, which are progenitors of
different types of cells, including endometrial cells. This evidence supports the hypothesis
that PRP stimulates some of the cellular processes involved in endometrial regeneration, that
can be relevant to the management of a thin lining.
Autologous Platelet-Rich Plasma is prepared from fresh whole blood which is collected from a
peripheral vein and processed to separate platelets from the other blood components. PRP
contains activating platelets that stimulate the action of cytokines and growth factors. On
the basis of this evidence, local intrauterine infusion of PRP may improve endometrial growth
and implantation.
Patients considered to be candidates for a PRP application must undergo a minor hematological
evaluation to exclude blood disorders or platelet dysfunction. The study, since it involves
the use of a blood component, was approved by Ethical Committee and all participant have to
sign an informed written consent before undergoing the procedure.
Any concerns of immunogenic reactions or disease transmission, that exist with homologous
blood products, are eliminated because PRP is produced from autologous blood. Preparation of
PRP, however, demands many processing steps, thus there is the theoretic possibility of
contamination. For these reasons, all samples are subjected to quality and sterility controls
within a closed mechanism. No wound infections after PRP applications have been reported.
Despite PGF has mitogenic properties, there is no evidence that the growth factors included
in PRP promote tumor growth or that they are involved in carcinogenesis.
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