Single-center Prospective Cumulus Cell Test Study in rFSH Patients

Universitair Ziekenhuis Brussel

Status: Unknown

Conditions: Infertility

Treatments: Diagnostic Test: CC-Test

Study type: Interventional

Funder types: Other

Identifiers

NCT03663868

BUN143201318000 b

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: Female

Ages: Under 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

CC-Test diagnosis and Day 3 transfer

Experimental group

Description:

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)

Treatment:

Diagnostic Test: CC-Test

Day 3 transfer control group

No Intervention group

Description:

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)

Day 5 transfer control group

No Intervention group

Description:

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)