Single-center Prospective Cumulus Cell Test Study in rFSH Patients
NCT ID: NCT03663868
Last Updated: 2018-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-08-14
2021-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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CC-Test diagnosis and Day 3 transfer
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)
CC-Test
Classification of the oocyte/embryo based on the gene expression pattern observed in the cumulus cells
Day 3 transfer control group
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 interventions assigned to this group
Day 5 transfer control group
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)
No interventions assigned to this group
Interventions
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CC-Test
Classification of the oocyte/embryo based on the gene expression pattern observed in the cumulus cells
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
FEMALE
No
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Principal Investigators
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Johan Smitz, Prof. Dr.
Role: STUDY_DIRECTOR
Universitair Ziekenhuis Brussel
Locations
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Universitair Ziekenhuis Brussel
Jette, Brussels Capital, Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BUN143201318000 b
Identifier Type: -
Identifier Source: org_study_id
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