Study for the Evaluation of "MitoScore" Marker in the Diagnosis of Embryo Viability in Euploids Embryos

NCT ID: NCT02662686

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1718 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-12-31

Brief Summary

The number of copies of mitochondrial genes (mtDNA or "MitoScore") is related to the energy supply of the embryo, which can affect its ability to implant in the maternal uterus.

The objective of this study is to analyse the potential of MitoScore before embryo transfer as a marker to identify and select the embryo with greater capacity of implantation. First of all, chromosomally normal embryos will be selected and mtDNA copies will be quantified. Finally, embryos with less copies of mtDNA will be considered for embryo transfer.

Detailed Description

The number of mitochondrial DNA copies (mtDNA) of a chromosomally normal embryo is related to a state of energy, which affects the ability of the embryo to implant in the maternal uterus. There is a decrease in the rate of implantation in euploid embryos containing a high number of mtDNA copies. It is known that after a certain number of mtDNA copies implantation is disrupted even in euploid embryos.

The main purpose of this study is to evaluate the possible relationship between the mtDNA content contained in developing embryos and the result of implantation in order to evaluate the potential of such relationship as a diagnostic tool.

The number of mtDNA copies present in chromosomally normal embryos will be quantified. Subsequently, the transfer of euploid embryos after the randomization will be using either routine morphological or MitoScore criteria.

Study population: women undergoing either IVF or egg donation that go through preimplantation genetic screening (PGS) for different indications, either in day 5/6 or day 3.

This is a triple blinded, randomized, prospective, clinical study where patients with embryos analyzed by PGS in blastocyst stage or day 3 and mitochondrial analysis with day 5/6 transfer, with deferred cycle for those analyzed in day 5/6 and fresh embryo transfer for those analyzed in day 3, will be randomized into two groups:

GROUP A: Embryo selection for transfer will be based initially on chromosomal normality and secondly on embryo morphology criteria (specific for IVF lab).

GROUP B: Embryo selection for transfer will be based initially on chromosomal normality and secondly on the MitoScore value, trying to transfer normal embryos containing the lowest number of mitochondrial DNA copies.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Control

Embryo selection for transfer will be based initially on chromosomally normal embryos and secondly on embryo morphology criteria (specific of IVF lab, as standard practice).

Group Type: ACTIVE_COMPARATOR

Transfer according to morphological criteria

Intervention Type: OTHER

Embryos will be analyzed by PGS and mitochondrial score on day 3 or day 5/6 biopsy and transferred on day 5/6, according to morphological criteria (control group).

MitoScore

Embryo selection for transfer will be based initially on chromosomal normality and secondly on the MitoScore value, trying to transfer chromosomally normal embryos which contain the lowest number of mitochondrial DNA copies.

Group Type: EXPERIMENTAL

Transfer according to the MitoScore results

Intervention Type: OTHER

Embryos will be analyzed by PGS and mitochondrial score on day 3 or day 5/6 biopsy and transferred on day 5/6, according to the MitoScore results (experimental group).

Interventions

Transfer according to morphological criteria

Embryos will be analyzed by PGS and mitochondrial score on day 3 or day 5/6 biopsy and transferred on day 5/6, according to morphological criteria (control group).

Intervention Type: OTHER

Transfer according to the MitoScore results

Embryos will be analyzed by PGS and mitochondrial score on day 3 or day 5/6 biopsy and transferred on day 5/6, according to the MitoScore results (experimental group).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• PGS cycles for different indications
• Maternal age: ≤40 years old (FIV/ICSI patients)
• Maternal age: <50 years old (OVODON patients)
• Spermatocyte concentration: > 2 million of spermatocyte/ml
• Single embryo transfer

-≥ 8 oocytes MII

• Number of Antral Follicules (AFC: ≥10 MII)

Exclusion Criteria

• Detection in the moment of inclusion or previous diagnosis of congenital uterine malformations.
• Patients with embryo sex selection for those countries in which it is allowed.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Igenomix

INDUSTRY

Sponsor Role: lead

Responsible Party

Antonio Diez

Product Innovation Leader

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Diez, BS PhD

Role: PRINCIPAL_INVESTIGATOR

Igenomix

Carlos Simon, MD PhD

Role: STUDY_DIRECTOR

Igenomix

Locations

IVI Las Palmas

Las Palmas de Gran Canaria, Las Palmas, Spain

IVI Madrid

Aravaca, Madrid, Spain

IVI Bilbao

Leioa, Vizcaya, Spain

IVI Alicante

Alicante, , Spain

IVI Barcelona

Barcelona, , Spain

IVI Malaga

Málaga, , Spain

IVI Murcia

Murcia, , Spain

IVI Vigo

Pontevedra, , Spain

IVI Sevilla

Seville, , Spain

IVI Valencia

Valencia, , Spain

IVI Zaragoza

Zaragoza, , Spain

Countries

Spain

Other Identifiers

1506-IGX-042-AD

Identifier Type: -

Identifier Source: org_study_id