Infertility
Conditions
Brief summary
Performing an additional non-invasive oocyte diagnostic test based on cumulus cell gene expression could improve the outcome of the ART cycle for rFSH stimulated patients
Interventions
DIAGNOSTIC_TESTCC-Test
Classification of the oocyte/embryo based on the gene expression pattern observed in the cumulus cells
Sponsors
Universitair Ziekenhuis Brussel
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 40 Years
Healthy volunteers
No
Inclusion criteria
* scheduled for intracytoplasmatic sperm injection (ICSI) and single (or double) embryo transfer on day 3 * patients down regulated with gonadotropin-releasing hormone (GnRH) antagonist and stimulated with recombinant Follicle Stimulating Hormone (FSH) * undergoing first or second IVF or ICSI cycle with transfer * Body Mass Index (BMI) between 17 and 33 * regular menstrual cycle (between 24 and 35 days)
Exclusion criteria
* smokers (\> 10 cigarettes per day) * patients requesting Pre-implantation Genetic Diagnosis (PGD) * patients with polycystic ovary syndrome (PCOS), or severe endometriosis (AFS stage 3-4) * couples where the partner has an extremely low sperm count i.e.: extreme oligo-astheno-teratozoospermia (OAT) (\< 100.000/ml) or scheduled for testicular sperm extraction (TESE) * results of eventual preceding cycles may not indicate a known genetic disease, or low ovarian response or an oocyte maturation defect
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy as observed by ultrasound | 2 months after embryo transfer | This observation is routinely performed by the treating physician for every patient undergoing standard ART treatment and is thus available from the fertility center database |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive beta-hCG pregnancy as observed by serum analysis | 12-17 days after embryo transfer | This observation is routinely performed by the treating physician for every patient undergoing standard ART treatment and is thus available from the fertility center database |
| Live birth by questionnaire | at least 9 months after embryo transfer | This observation is routinely performed by the study nurses of the fertility center for every patient undergoing standard ART treatment and is thus available from the fertility center database. This measurement does not include a scale, there is either a child born or not. The date of delivery and the gender of the child are asked together with eventual complications. |
| Cumulative pregnancy by ultrasound (for pregnancy follow-up) and questionnaire (for live birth follow-up) (see outcome 1 and 3) | 2 years after embryo transfer | This is the compilation of the data gathered in outcome 1 and 3 for eventual consecutive cycles. This observation is routinely performed by the study nurses of the fertility center for every patient undergoing standard ART treatment and is thus available from the fertility center database |
Countries
Belgium
Contacts
Primary ContactInge Van Vaerenbergh, PhD
Backup ContactTom Adriaenssens, MSc
Outcome results
None listed