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

Infertility Clinical Trial

— MitoScore  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02662686
• Other study ID #: 1506-IGX-042-AD
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: Igenomix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1718
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Infertility

Intervention

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).
• 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).

Locations

Country	Name	City	State
Spain	IVI Alicante	Alicante
Spain	IVI Madrid	Aravaca	Madrid
Spain	IVI Barcelona	Barcelona
Spain	IVI Las Palmas	Las Palmas de Gran Canaria	Las Palmas
Spain	IVI Bilbao	Leioa	Vizcaya
Spain	IVI Malaga	Malaga
Spain	IVI Murcia	Murcia
Spain	IVI Vigo	Pontevedra
Spain	IVI Sevilla	Sevilla
Spain	IVI Valencia	Valencia
Spain	IVI Zaragoza	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Igenomix

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implantation rate		20 days
Primary	Pregnancy rate		12 days
Secondary	Miscarriage rate		9 months
Secondary	Ongoing pregnancy rate		9 months