Cumulus Cell Messenger Ribonucleic Acid (mRNA) Analysis as Oocyte Quality Marker in the Fertility Lab in a Prospective Single-center Study
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Clinical pregnancy as observed by ultrasound
Study Overview
Brief Summary
Performing an additional non-invasive oocyte diagnostic test based on cumulus cell gene expression could improve the outcome of the ART cycle
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- — to 40 Years (Child, Adult)
- Sex
- Female
- Accepts 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 Highly Purified human Menopausal Gonadotropin (HP-hMG)
- •undergoing first or second IVF or ICSI cycle with transfer
- •Body Mass Index (BMI) between 17 and
- •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 e.g.: 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
Arms & Interventions
Day 3 transfer control group
Patients undergo the standard ART treatment, as prescribed by the treating physician, with standard morphology based scoring of the embryos and transfer of the best embryo based on day 3 of embryo growth (cleavage stage embryo)
CC-Test diagnosis and Day 3 transfer
Patients undergo the standard ART treatment, as prescribed by the treating physician, with standard morphology based scoring of the embryos + the extra cumulus cell based diagnosis and transfer of the best embryo based on morphology and CC diagnosis on day 3 of embryo growth (cleavage stage embryo)
Intervention: CC-Test (Other)
Day 5 transfer control group
Patients undergo the standard ART treatment, as prescribed by the treating physician, with standard morphology based scoring of the embryos and transfer of the best embryo based on day 5 of embryo growth (blastocyst stage embryo)
Outcomes
Primary Outcomes
Clinical pregnancy as observed by ultrasound
Time Frame: 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 Outcomes
- Live birth by questionnaire(at least 9 months after embryo transfer)
- Cumulative pregnancy(2 years after embryo transfer)
- Positive beta-hCG Pregnancy as observed by serum analysis(12-17 days after embryo transfer)