QUALIMORPH - Embryo quality evaluation in Intra Cytoplasmic Sperm Injection (ICSI) cycles with Fertimorph system 
Head :
Niez Philipe
Arbo Elisangela
Arbo Elisangela
Last update : 01/01/2020 | Version : 1 | ID : 197
| General | |
| Identification | |
| Detailed name | Embryo quality evaluation in Intra Cytoplasmic Sperm Injection (ICSI) cycles with Fertimorph system |
| Sign or acronym | QUALIMORPH |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL (22/12/2009) |
| General Aspects | |
| Medical area |
Biology |
| Health determinants |
Iatrogenic |
| Others (details) | Infertility |
| Keywords | In Vitro Fertilization (IVF), FertiMORPH system, embryo quality, Intra Cytoplasmic Sperm Injection ICSI |
| Scientific investigator(s) (Contact) | |
| Name of the director | Niez |
| Surname | Philipe |
| Address | 07 rue Jean Baptiste Clement 94250, Gentilly |
| Phone | + 33 (0)1 49 08 85 16 |
| philippe.niez@ferring.com | |
| Name of the director | Arbo |
| Surname | Elisangela |
| Address | 07 rue Jean Baptiste Clement 94250, Gentilly |
| Phone | +33 (0)1 49 08 91 23 |
| elisangela.arbo@ferring.com | |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Ferring SAS |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Ferring SAS |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Not-repeated cross-sectional studies (except case control studies) |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Another treatment or procedure |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective | Evaluate the concordance between the embryo quality appreciated by the biologist according to his normal technique and according to the Fertimorph system |
| Inclusion criteria |
Embryos coming from couples having the following characteristics: -Criteria linked to the woman: woman with normal response, all infertility etiologies, aged up to 36 years, maximum of one prior assisted reproduction technique (ART) cycle, current ART cycle with ICSI with ejaculated or frozen sperm, normal ovarian reserve (evaluated via hormone assays and where applicable by an antral follicle count), with a normal uterus and without hydrosalpinx. -Criteria linked to the spouse: diagnosed male infertility, where applicable normal male karyotype, -Criteria linked to the studied attempt: at least 5 mature (MII) ovocytes retrieved, maximum of two embryos transferred. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) |
| Population covered |
Sick population |
| Gender |
Woman |
| Geography area |
National |
| Detail of the geography area | Multi-center study - 7 centers in France: Besançon, Grenoble, Lille, Montpellier, Strasbourg, Toulouse, Brest |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2010 |
| Date of last collection (YYYY or MM/YYYY) | 2010 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 130 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Biological data (detail) | Number and quality of the ovocytes, fertilization parameters, number and quality of the embryos |
| Presence of a biobank |
No |
| Health parameters studied |
Others |
| Other (detail) | Biological parameters: embryo quality and development |
| Procedures | |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Under discussion |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
