Status:
COMPLETED
Aurora Test for Patients Treated With Recombinant Gonadotropins
Lead Sponsor:
Fertiga, Belgium
Collaborating Sponsors:
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Conditions:
Infertility
Eligibility:
FEMALE
22-38 years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT04710264
Start Date
February 15 2021
End Date
September 1 2025
Last Update
September 8 2025
Active Locations (1)
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1
Universitair Ziekenhuis Brussel
Jette, Belgium, 1090