Aurora Test for Patients Treated With Recombinant Gonadotropins

An Observational Cohort Study to Evaluate the Expression Profiles of Oocyte-potency-related Genes in Ovarian Cumulus Cells From Patients Treated by Intracytoplasmic Sperm Injection (ICSI) That Are Treated With Recombinant Gonadotropins

This is an observational study. The main aim is to determine the expression of potential biomarker genes in the cumulus cells isolated from individual oocytes in two patient cohorts: recombinant human Follicle Stimulating Hormone(hFSH) and recombinant hFSH:human Luteinizing Hormone(r-hLH) ratio 2:1. Algorithms from gene combinations will be identified that predict embryo quality and pregnancy outcomes.

Inclusion Criteria:

• Patients are between 22-38 years old
• BMI between 17-33
• provide written informed consent
• Patients undergoing a first or second ICSI treatment cycle.
• Patients will be treated by ICSI (intracytoplasmic sperm injection)
• Patients agree that the oocytes will be denuded for cumulus testing and agree to the single blastocyst transfer.
• Patients must be predicted good ovarian responders (AMH 1-4,7 ng/ml) with 7-18 follicles of minimum 10-11 mm on trigger day (oocyte retrieval minus 2 days (OR -2)) by ultrasound following ovarian stimulation with r-hFSH or r-hFSH with r-hLH in a Gonadotropin-releasing hormone (GnRH) antagonist protocol (starting dose recombinant Follicle Stimulating Hormone (rFSH) between 150-225 IU)
• HCG trigger after stimulation (r-hCG)

Exclusion Criteria:

• Women with less than 7 or more than 18 follicles at Day -2 or -3 measured by ultrasound
• Women with history of poor oocyte maturation or known maturation defect
• Irregular menstrual cycle (< 24 or > 35 days)
• BMI < 17 or > 33
• Smoking > 10 cigarettes per day.
• Known low ovarian response based on Bologna criteria
• Combined use of urinary and recombinant gonadotropins in the current cycle
• Patients with severe endometriosis ≥ III (AFS classification)
• Polycystic ovary syndrome (PCOS), defined by revised criteria American Society for Reproductive Medicine (ASRM) European Society of Human Reproduction and Embryology (ESHRE) 2018
• Patient included in any other study
• Patient scheduled for preimplantation genetic testing (PGT)
• Testicular sperm extraction (TESE) or extreme oligo-astheno-teratozoospermia (OAT) with sperm count below 100.000/ml.