Improvement of in Vitro Fertilization Implantation by Soluble CD146 Dose in Embryonic Culture Environment

in Vitro Fertilization Clinical Trial

— AMIFIV  

Official title:

Improvement of in Vitro Fertilization Implantation by Soluble CD146 Dose in Embryonic Culture Environment : Multicenter Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03785119
• Other study ID #: 2018-20
• Status: Not yet recruiting
• Start date: January 2019
• Est. completion date: January 2023

Study information

• Verified date: December 2018
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Odile Lacroix-Paulmyer, PUPH
• Phone: +33 (0)4 91 38 13 78
• Email: odile.lacroix-paulmyer[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 318
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 42 Years

Eligibility

Pre Inclusion Criteria:

• Women aged [18;42] years

• 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

Inclusion Criteria:

• FET realization in the selected population

Exclusion Criteria:

• Refusal to participate at the study of at least one member of the couple

• 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

Related Conditions & MeSH terms

• in Vitro Fertilization

Locations

Country	Name	City	State
France	Service de Biologie de la Reproduction	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beginner pregnancy rate at 1st transfer (%)	Corresponds to number of defined pregnancy by plasmatic quantity of hCG (human chorionic gonadotropin) >100 UI/l 15 days after FET/number of FET.	0 to 9 months after FET
Secondary	Beginner pregnancy rate at 2nd or 3rd transfer	Corresponds to number of defined pregnancy by plasmatic quantity of hCG >100 UI/l 15 days after FET/number of FET.	0 to 9 months after FET