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

August 7, 2018 updated by: Antonio Diez, Igenomix

Randomized Multi-centric Prospective Study for the Evaluation of "MitoScore" Marker in the Diagnosis of Embryo Viability in Euploids Embryos.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1718

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03015
        • IVI Alicante
      • Barcelona, Spain, 08017
        • IVI Barcelona
      • Malaga, Spain, 29016
        • IVI Málaga
      • Murcia, Spain, 30007
        • IVI Murcia
      • Pontevedra, Spain, 35203
        • IVI Vigo
      • Sevilla, Spain, 41011
        • IVI Sevilla
      • Valencia, Spain, 46015
        • IVI Valencia
      • Zaragoza, Spain, 50018
        • IVI Zaragoza
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35019
        • IVI Las Palmas
    • Madrid
      • Aravaca, Madrid, Spain, 28023
        • IVI Madrid
    • Vizcaya
      • Leioa, Vizcaya, Spain, 48940
        • IVI Bilbao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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).
Other: 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).
Experimental: 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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Implantation rate
Time Frame: 20 days
20 days
Pregnancy rate
Time Frame: 12 days
12 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Miscarriage rate
Time Frame: 9 months
9 months
Ongoing pregnancy rate
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Igenomix

Investigators

  • Principal Investigator: Antonio Diez, BS PhD, Igenomix
  • Study Director: Carlos Simon, MD PhD, Igenomix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

January 14, 2016

First Submitted That Met QC Criteria

January 22, 2016

First Posted (Estimate)

January 25, 2016

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1506-IGX-042-AD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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