Single-center Prospective Cumulus Cell Test Study (CC-Test)

Universitair Ziekenhuis Brussel

Status: Unknown

Conditions: Pregnancy

Treatments: Other: CC-Test

Study type: Interventional

Funder types: Other

Identifiers

NCT03659786

BUN143201318000

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

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 Highly Purified human Menopausal Gonadotropin (HP-hMG)
• 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 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

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 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)

Treatment:

Other: CC-Test

Day 3 transfer control group

No Intervention group

Description:

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)

Day 5 transfer control group

No Intervention group

Description:

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)