Single-center Prospective Cumulus Cell Test Study

Universitair Ziekenhuis Brussel100 enrolled

Overview

Performing an additional non-invasive oocyte diagnostic test based on cumulus cell gene expression could improve the outcome of the ART cycle

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Pregnancy

Interventions

CC-TestOTHER

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

Eligibility

Sex: FEMALEMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium

Outcomes

Primary Outcomes

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

Time frame: 2 months after embryo transfer

Secondary Outcomes

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

Time frame: 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.

Time frame: at least 9 months after embryo transfer

Cumulative pregnancy

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.

Time frame: 2 years after embryo transfer

Data from ClinicalTrials.gov

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