InfertilityAURORA-RECNCT04710264
Aurora Test for Patients Treated With Recombinant Gonadotropins
An observational study of Infertility, run by Fertiga, Belgium at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 38 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- AURORA-Rec
- How many people
- 137 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Feb 2021to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 38 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- AURORA-Rec
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AURORA-RecOther
Explorative study of cumulus cells gene expression in relation to the patient treatment and oocyte competence.
| Study group | Role | What they receive |
|---|---|---|
| recombinant hFSH | Patient stimulated with recombinant hFSH Receives: Other: AURORA-Rec | |
| recombinant hFSH : r-hLH | Patient stimulated with recombinant hFSH : r-hLH ratio 2:1 Receives: Other: AURORA-Rec |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years after study start
Secondary outcomes (9)
Meiosis II Oocyte rate
The number of meiosis II oocytes (nominator) divided by the total number of oocytes retrieved (denominator)
Measured: Day 0 of embryo collection
Normal fertilization rate
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
Measured: Day 1 of embryo culture
Day 5 good-quality embryo rate
Defined as the proportion of 2PN zygotes which are good-quality blastocysts on Day 5
Measured: Day 5 of embryo culture
Embryo utilization rate
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
Measured: Day 5 of embryo culture
Biochemical pregnancy rate
A pregnancy diagnosed only by the detection of beta human chorionic gonadotropin (hCG) in serum or urine
Measured: Day 10 after embryo transfer
Fetal heart beat positive implantation rate
Rate refers to the proportion of fetal heartbeats detected relative to the number of embryos transferred
Measured: Week 5-6 after embryo transfer
Clinical pregnancy rate
Pregnancy diagnosed by ultrasonographic or clinical documentation of at least one fetus with a discernible heartbeat in gestational week 6 to 8
Measured: Week 5-6 after embryo transfer
Ongoing pregnancy rate
The presence of gestational sacs with fetal heart beat detected by transvaginal ultrasound examination in gestational week 10 to 11
Measured: Week 10-11 after embryo transfer
Miscarriage rate
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.
Measured: Week 12 after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start15 Feb 2021
- Primary completion31 Dec 2023
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fertiga, Belgium
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710264
- Sponsor's protocol ID
- 2020.Aurora-Rec
- Acronym
- AURORA-REC
- Status last verified
- Sep 2025
- First submitted
- 9 Jan 2021
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41275247
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04710264
- Acronym / sponsor ID
- AURORA-REC / 2020.Aurora-Rec
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Fertiga, BelgiumIndustry (pharma, biotech, devices)
- Collaborators
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| recombinant hFSH | – | Other: AURORA-RecPatient stimulated with recombinant hFSH |
| recombinant hFSH : r-hLH | – | Other: AURORA-RecPatient stimulated with recombinant hFSH : r-hLH ratio 2:1 |
Who may qualify
- Ages
- 22 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AURORA-RecExplorative study of cumulus cells gene expression in relation to the patient treatment and oocyte competence. | Other | recombinant hFSH, recombinant hFSH : r-hLH |
Primary outcome
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.
9 secondary outcomes
Meiosis II Oocyte rate
Time frame: Day 0 of embryo collection
Normal fertilization rate
Time frame: Day 1 of embryo culture
Day 5 good-quality embryo rate
Time frame: Day 5 of embryo culture
Embryo utilization rate
Time frame: Day 5 of embryo culture
Biochemical pregnancy rate
Time frame: Day 10 after embryo transfer
Fetal heart beat positive implantation rate
Time frame: Week 5-6 after embryo transfer
Clinical pregnancy rate
Time frame: Week 5-6 after embryo transfer
Ongoing pregnancy rate
Time frame: Week 10-11 after embryo transfer
Miscarriage rate
Time frame: Week 12 after embryo transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Derived from this study: PubMed 41275247Adriaenssens 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Fertiga, Belgium at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normalized messenger ribonucleic acid (mRNA) expression (time frame: 3 years after study start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04710264, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025; AzTrials last refreshed its copy on 1 Nov 2026.