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

Sponsor

Igenomix (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02662686

Collaborator

(none)

1,718

Enrollment

Locations

Arms

Duration (Months)

156.2

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Other: Transfer according to morphological criteria Other: Transfer according to the MitoScore results	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1718 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Implantation rate [20 days]
Pregnancy rate [12 days]

Secondary Outcome Measures

Miscarriage rate [9 months]
Ongoing pregnancy rate [9 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IVI Las Palmas	Las Palmas de Gran Canaria	Las Palmas	Spain	35019
2	IVI Madrid	Aravaca	Madrid	Spain	28023
3	IVI Bilbao	Leioa	Vizcaya	Spain	48940
4	IVI Alicante	Alicante		Spain	03015
5	IVI Barcelona	Barcelona		Spain	08017
6	IVI Malaga	Malaga		Spain	29016
7	IVI Murcia	Murcia		Spain	30007
8	IVI Vigo	Pontevedra		Spain	35203
9	IVI Sevilla	Sevilla		Spain	41011
10	IVI Valencia	Valencia		Spain	46015
11	IVI Zaragoza	Zaragoza		Spain	50018