Aurora Test for Patients Treated With Recombinant Gonadotropins (AURORA-REC)

Fertiga

Status

Completed

Conditions

Infertility

Treatments

Other: AURORA-Rec

Study type

Observational

Funder types

Industry

Identifiers

NCT04710264

2020.Aurora-Rec

Details and patient eligibility

About

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.

Enrollment

137 patients

Sex

Female

Ages

22 to 38 years old

Volunteers

No Healthy Volunteers

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.