NCT02662686

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,718

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 25, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

2.9 years

First QC Date

January 14, 2016

Last Update Submit

August 7, 2018

Conditions

Infertility

Keywords

Embryo ImplantationMitochondrial genesMitochondrial DNAMitoScoreEmbryo selectionEmbryo viabilityEmbryo biomarkerDiagnosis of embryo viability in euploids embryos

Outcome Measures

Primary Outcomes (2)

  • Implantation rate

    20 days

  • Pregnancy rate

    12 days

Secondary Outcomes (2)

  • Miscarriage rate

    9 months

  • Ongoing pregnancy rate

    9 months

Study Arms (2)

Control

ACTIVE COMPARATOR

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

MitoScore

EXPERIMENTAL

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

Interventions

Transfer according to morphological criteriaOTHER

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).

Control
Transfer according to the MitoScore resultsOTHER

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).

MitoScore

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Patients with embryo sex selection for those countries in which it is allowed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

IVI Las Palmas

Las Palmas de Gran Canaria, Las Palmas, 35019, Spain

Location

IVI Madrid

Aravaca, Madrid, 28023, Spain

Location

IVI Bilbao

Leioa, Vizcaya, 48940, Spain

Location

IVI Alicante

Alicante, 03015, Spain

Location

IVI Barcelona

Barcelona, 08017, Spain

Location

IVI Malaga

Málaga, 29016, Spain

Location

IVI Murcia

Murcia, 30007, Spain

Location

IVI Vigo

Pontevedra, 35203, Spain

Location

IVI Sevilla

Seville, 41011, Spain

Location

IVI Valencia

Valencia, 46015, Spain

Location

IVI Zaragoza

Zaragoza, 50018, Spain

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Antonio Diez, BS PhD

    Igenomix

    PRINCIPAL INVESTIGATOR

  • Carlos Simon, MD PhD

    Igenomix

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Product Innovation Leader

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 25, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

August 8, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(11)