Aurora Test for Patients Treated With Recombinant Gonadotropins

NCT04710264 | Completed

• 1 other identifier: 2020.Aurora-Rec
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Normalized messenger ribonucleic acid (mRNA) expression

  Normalized mRNA levels of biomarker genes that are assessed in cumulus cells by reverse transcription quantitative Polymerase Chain Reaction (RT-qPCR) for each oocyte.

  3 years after study start

Secondary Outcomes (9)

• Meiosis II Oocyte rate

  Day 0 of embryo collection

• Normal fertilization rate

  Day 1 of embryo culture

• Day 5 good-quality embryo rate

  Day 5 of embryo culture

• Embryo utilization rate

  Day 5 of embryo culture

• Biochemical pregnancy rate

  Day 10 after embryo transfer

Other Outcomes (3)

• Cumulative ongoing pregnancy rate

  3 years after study start

• Live Birth rate

  Week 24-42 after embryo transfer

• Cumulative Live Birth rate

  3 years after study start

Study Arms (2)

recombinant hFSH

Patient stimulated with recombinant hFSH

Other: AURORA-Rec

recombinant hFSH : r-hLH

Patient stimulated with recombinant hFSH : r-hLH ratio 2:1

Other: AURORA-Rec

Interventions

AURORA-Rec OTHER

Explorative study of cumulus cells gene expression in relation to the patient treatment and oocyte competence.

recombinant hFSH; recombinant hFSH : r-hLH

Eligibility Criteria

• Age: 22 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fertiga, Belgium: lead
• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

Location

Related Publications (1)

• Adriaenssens T, Van Vaerenbergh I, Van Leuven W, Coucke W, Montenegro S, Zheng W, D'Hooghe T, Van Landuyt L, De Munck N, Van Hecke E, Smitz J, Rosenthal A, Blockeel C. Live birth in patients stimulated with r-hFSH or r-hFSH: r-hLH is strongly associated with cumulus cell derived gene expression models. Reprod Biol Endocrinol. 2025 Nov 22;23(1):163. doi: 10.1186/s12958-025-01480-2.

  PMID: 41275247 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2021
• First Posted: January 14, 2021
• Study Start: February 15, 2021
• Primary Completion: December 31, 2023
• Study Completion: September 1, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)