Skip to main content
OpenTrials
Completed

NCT Number: NCT04710264

Aurora Test for Patients Treated With Recombinant Gonadotropins

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

22 year–38 year

Sex eligibility

Female

Study type

Observational

Primary location

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AURORA-Rec

Other

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

Primary outcomes

  1. Normalized messenger ribonucleic acid (mRNA) expression

    Time frame: 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 outcomes

  1. Meiosis II Oocyte rate

    Time frame: Day 0 of embryo collection

    The number of meiosis II oocytes (nominator) divided by the total number of oocytes retrieved (denominator)

  2. Normal fertilization rate

    Time frame: 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

  3. Day 5 good-quality embryo rate

    Time frame: Day 5 of embryo culture

    Defined as the proportion of 2PN zygotes which are good-quality blastocysts on Day 5

  4. Embryo utilization rate

    Time frame: 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

  5. Biochemical pregnancy rate

    Time frame: Day 10 after embryo transfer

    A pregnancy diagnosed only by the detection of beta human chorionic gonadotropin (hCG) in serum or urine

  6. Fetal heart beat positive implantation rate

    Time frame: Week 5-6 after embryo transfer

    Rate refers to the proportion of fetal heartbeats detected relative to the number of embryos transferred

  7. Clinical pregnancy rate

    Time frame: 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

  8. Ongoing pregnancy rate

    Time frame: 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

  9. Miscarriage rate

    Time frame: 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.

Other outcomes

  1. Cumulative ongoing pregnancy rate

    Time frame: 3 years after study start

    The accumulated ongoing pregnancy after fresh and frozen-warmed embryo transfers within one stimulation cycle. Pregnancy with detectable heart rate at ≥ 12 weeks gestation after the completion of the first transfer

  2. Live Birth rate

    Time frame: Week 24-42 after embryo transfer

    is defined as the birth of at least one newborn after 24 weeks gestation that exhibits any sign of live (twins will be a single count)

  3. Cumulative Live Birth rate

    Time frame: 3 years after study start

    The number of deliveries with at least one live birth resulting from one initiated or aspirated artificial reproductive technologies (ART) cycle, including all cycles in which fresh and/or frozen embryos are transferred, until one delivery with a live birth occurs or until all embryos are used, whichever occurs first.

Sponsors and collaborators

Lead sponsor

Fertiga, Belgium

Industry

Collaborators

  • Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Registry information

Official study 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

Acronym: AURORA-REC

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Jan 14, 2021
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.