Single-center Prospective Cumulus Cell Test Study

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2018-11-30

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

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Detailed Description

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Conditions

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Pregnancy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

CC-Test

Intervention Type OTHER

Classification of the oocyte/embryo based on the expression pattern observed in the cumulus cells

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)

Group Type NO_INTERVENTION

No interventions assigned to this group

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)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CC-Test

Classification of the oocyte/embryo based on the expression pattern observed in the cumulus cells

Intervention Type OTHER

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 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

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No