Aurora Test for Patients Treated With Recombinant Gonadotropins

Active, not recruiting

• Conditions: Infertility
• Interventions: Other: AURORA-Rec

• Registration Number: NCT04710264
• Lead Sponsor: Fertiga, Belgium

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-09
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-14
• Study Start: 2021-02-15
• Primary Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-02
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 137

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
recombinant hFSH	AURORA-Rec	Patient stimulated with recombinant hFSH
recombinant hFSH : r-hLH	AURORA-Rec	Patient stimulated with recombinant hFSH : r-hLH ratio 2:1

Primary Outcome Measures

Name	Time	Method
Normalized messenger ribonucleic acid (mRNA) expression	3 years after study start	Normalized mRNA levels of biomarker genes that are assessed in cumulus cells by reverse transcription quantitative Polymerase Chain Reaction (RT-qPCR) for each oocyte.

Secondary Outcome Measures

Name	Time	Method
Fetal heart beat positive implantation rate	Week 5-6 after embryo transfer	Rate refers to the proportion of fetal heartbeats detected relative to the number of embryos transferred
Clinical pregnancy rate	Week 5-6 after embryo transfer	Pregnancy diagnosed by ultrasonographic or clinical documentation of at least one fetus with a discernible heartbeat in gestational week 6 to 8
Ongoing pregnancy rate	Week 10-11 after embryo transfer	The presence of gestational sacs with fetal heart beat detected by transvaginal ultrasound examination in gestational week 10 to 11
Meiosis II Oocyte rate	Day 0 of embryo collection	The number of meiosis II oocytes (nominator) divided by the total number of oocytes retrieved (denominator)
Normal fertilization rate	Day 1 of embryo culture	The number of fertilized oocytes on Day 1 (presence of 2 pronuclei (2PN) and the second polar body (2PB) assessed at 17 ± 1 h postinsemination, as a function of all cumulus-oocytes complexes (COCs) inseminated
Embryo utilization rate	Day 5 of embryo culture	Defined as the number of embryos (or blastocysts) suitable for transfer or cryopreservation as a function of the number of normally fertilized (2PN) oocytes observed on Day 1
Day 5 good-quality embryo rate	Day 5 of embryo culture	Defined as the proportion of 2PN zygotes which are good-quality blastocysts on Day 5
Biochemical pregnancy rate	Day 10 after embryo transfer	A pregnancy diagnosed only by the detection of beta human chorionic gonadotropin (hCG) in serum or urine
Miscarriage rate	Week 12 after embryo transfer	The spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age. In this study we capture spontaneous miscarriage till gestational week 12.

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Belgium