Improvement of in Vitro Fertilization Implantation by Soluble CD146 Dose in Embryonic Culture Environment
NCT ID: NCT03785119
Last Updated: 2018-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
318 participants
OBSERVATIONAL
2019-01-31
2023-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Standard strategy
According to embryo quality (morphologic criteria)
No interventions assigned to this group
Experimental strategy
Association of embryo quality and sCD146 rate
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Men aged \> 18 years
* Trying an IVF with :
* Frozen supernumerary embryo after fresh embryo transfer realised at the end of the try or frozen embryo (frozen all), without immediately transfer possibility (ovulation hyperstimulation context/ hyperprogesteronemia for example)
* Freezing at least 2 embryos frozen separately (1/vial)
* Whatever attempt rank
* Whatever MAP (Medically Assisted Procreation) technics (IVF/ICSI)
* Potential transfer of one frozen embryo
* Volunteer couples to participate at the study, received informations about this protocol and giving both their non opposition
\- FET realization in the selected population
Exclusion Criteria
* Inclusion realized for a previous attempt
* IVF try with a third-party
* IVF try without embryo freezing
* Freezing only one embryo
* Non separately freezing of embryos (2/vial)
* Female patients \<18 years and \>42 years
* Male patients \<18 years
18 Years
42 Years
ALL
Yes
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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Jean Olivier Arnaud
Role: STUDY_DIRECTOR
Assistance Publique Hôpitaux de Marseille
Locations
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Service de Biologie de la Reproduction
Marseille, , France
Countries
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Central Contacts
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Facility Contacts
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Odile Lacroix-Paulmyer, PUPH
Role: primary
Other Identifiers
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2018-20
Identifier Type: -
Identifier Source: org_study_id