Clinical trial NCT04710264: Aurora Test for Patients Treated With Recombinant Gonadotropins
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Infertility
Lead sponsor: Fertiga, Belgium
Sponsor class: INDUSTRY
Collaborators: name: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
First posted: 2021-01-14
Enrollment: 137
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients for this study must be between 22-38 years of age, have a good ovarian reserve and response, and need to be naïve to IVF/ ICSI or have only one prior ICSI cycle. Only patients with 7-18 follicles at the end of ovarian stimulation will be allowed to enter the study on the day of decision of hCG injection (or the day before). Patients with fewer than 7 oocytes will be excluded from the study.

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Normalized messenger ribonucleic acid (mRNA) expression
timeFrame: 3 years after study start
Secondary outcomes:
measure: Meiosis II Oocyte rate
timeFrame: Day 0 of embryo collection
measure: Normal fertilization rate
timeFrame: Day 1 of embryo culture
measure: Day 5 good-quality embryo rate
timeFrame: Day 5 of embryo culture
measure: Embryo utilization rate
timeFrame: Day 5 of embryo culture
measure: Biochemical pregnancy rate
timeFrame: Day 10 after embryo transfer
measure: Fetal heart beat positive implantation rate
timeFrame: Week 5-6 after embryo transfer
measure: Clinical pregnancy rate
timeFrame: Week 5-6 after embryo transfer
measure: Ongoing pregnancy rate
timeFrame: Week 10-11 after embryo transfer
measure: Miscarriage rate
timeFrame: Week 12 after embryo transfer
Other outcomes:
measure: Cumulative ongoing pregnancy rate
timeFrame: 3 years after study start
measure: Live Birth rate
timeFrame: Week 24-42 after embryo transfer
measure: Cumulative Live Birth rate
timeFrame: 3 years after study start
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
Study officials:
References: