in Vitro Fertilization Clinical Trial
Official title:
Improvement of in Vitro Fertilization Implantation by Soluble CD146 Dose in Embryonic Culture Environment : Multicenter Prospective Study
The study of implantation potential of the embryo stay a priority in In Vitro Fertilization
(IVF). Indeed, the selection of embryos to transfer is actually based in routine check on
morphologic criteria, approved by literature but not perfect. Implantation's markers
identification, allowing to choose the embryo(s) to transfer and then decrease pregnancy
failure, represent a major issue in IVF, not any biomarker being approved yet.
Among factors regulating embryonic implantation, investigators have recently proposed soluble
CD146, coming from proteolytic cleavage of the CD146 membrane, angiogenic bond molecule.
In a monocentric study about 222 transferred embryos at the end of IVF try, investigators
showed that the sCD146 dose in the embryonic culture environment reflected the implantation
ability of embryo, a high rate showing a low implantation potential and this independently of
the embryonic quality. A multicentric prospective study is now required to confirm the
utility of this dosage in clinical practice.
Primary objective : Compared 2 frozen embryo transfer (FET) strategies in terms of
implantation efficiency, according to choice method of embryo to be transferred :
- Group A : Standard strategy : Depending on embryonic quality according to criteria
currently selected.
- Group B : Experimental strategy : Association of embryonic quality according to criteria
currently selected and of sCD146 rate.
Expected Results :
- Demonstrate a beginning pregnancy test significantly superior in Group B compared to
Group A.
- Confirmed that sCD146 is an independent biomarker of morphologic embryonic quality
(actual selection criteria) and represent a complementary criteria to choose embryos to
transfer.
Methodology :
- Multicentric prospective study with 2 groups of Frozen Embryo Transfer (FET); The
calculation of the number of staff required includes 151 couples per group.
For this will be include for 24 months, couples benefiting of freezing at least one of the
two embryos and transfer of only one FET.
- Test the same day of environment freezing where frozen embryos were cultivated. sCD146
dosage by ELISA technic (Enzyme Linked ImmunoSorbent Assay) in thus culture environment
before FET.
- Implantation potential analyze of each transfer embryo (FET) according to sCD146 rate.
- Following of the FET future(pregnancy, childbirth) : maximum 9 months after attempt to
each included couple.
n/a
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