Single-center Prospective Cumulus Cell Test Study in rFSH Patients

Study Overview
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Brief Summary
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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

Official Title
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Cumulus Cell mRNA Analysis as Oocyte Quality Marker in the Fertility Lab in a Prospective Single-center Study for rFSH Stimulated Patients

Conditions
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Infertility

Intervention / Treatment
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* Diagnostic Test: CC-Test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CC-Test diagnosis and Day 3 transfer<br>Patients undergo the standard ART treatment, as described 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) | Diagnostic Test: CC-Test<br>* Classification of the oocyte/embryo based on the gene expression pattern observed in the cumulus cells<br>|
| No Intervention: Day 3 transfer control group<br>Patients undergo the standard ART treatment, as described by the treating physician, with standard morphology based scoring of the embryos and transfer of the best embryo based on morphology on day 3 of embryo growth (cleavage stage embryo) | |
| No Intervention: Day 5 transfer control group<br>Patients undergo the standard ART treatment, as described by the treating physician, with standard morphology based scoring of the embryos and transfer of the best embryo based on morphology on day 5 of embryo growth (blastocyst stage embryo) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy as observed by ultrasound | 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 | 2 months after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive beta-hCG pregnancy as observed by serum analysis | 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 | 12-17 days after embryo transfer | 
| Live birth by questionnaire | 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. | at least 9 months after embryo transfer | 
| Cumulative pregnancy by ultrasound (for pregnancy follow-up) and questionnaire (for live birth follow-up) (see outcome 1 and 3) | 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 | 2 years after embryo transfer |