InfertilityNCT06280677
Aurora Test for ART Donor Patients (AURORA-Donor)
An observational study of Infertility, run by Fertiga, Belgium at 1 site in Spain.
Trial summary
This is a randomized observational study. The main aim is to determine potential oocyte competence predictive mRNA expression profiles in the cumulus cells isolated form individual oocytes. In 2 patient cohorts: 1)GnRH Antagonist \& hr-FSH with GnRH Agonist trigger, 2) Progesterone \& hr-FSH with GnRH Agonist trigger. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- AURORA-Donor
- How many people
- 160 participants
- Where
- 1 siteSpain
- Study dates
- 16 Feb 2024to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Donor's for this study must be between 18 and 35 years of age, and compliant with SEF directive for egg donation. Only patient with at least 6 MII will be included in the study.
Who may be able to join
- Patients are 18 to 35 years old
- BMI between 17-30
- Regular menstrual cycles
- AFC > 8
- Patient profile in compliance with SEF (Sociedad Española de Fertilidad) directives for egg donation (medical, psychological and genetic screening, informed consent)
- Patients' stimulation: GnRH Antagonist \& hr-FSH with GnRH Agonist trigger or Progesterone \& hr-FSH with GnRH Agonist trigger
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- Patients agree that the oocytes will be denuded for cumulus testing and provide written informed consent for participation to the study
- Patients applying for ART egg donation with fresh/frozen sperm from the partner or frozen donor sperm. With eSB-FET in modified natural cycle or an HRT cycle.
- Patients are from 18 to 50 years old.
- Patients will be treated by ICSI (intracytoplasmic sperm injection) and eSB-FET (elective Single Blastocyst Frozen Embryo Transfer)
- Recipient patients agree that the donors' oocytes will be denuded for cumulus testing and provide written informed consent for participation to the study
Who cannot join
- BMI < 17 or > 30
- Extreme irregular menstrual cycles (<20 days or >40 days)
- AFC < 8
- <8 MII on previous egg retrieval
- Women with history of poor oocyte maturation or known maturation defect or unexplained failure in previous treatments
- Patients that fail to comply with SEF (Sociedad Española de Fertilidad) directives for egg donation (medical, psychological and genetic screening, informed consent)
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- Patient included in any other prospective study.
- BMI < 17 or > 35
- Severe uterine factor: Multiple myomectomy, multiple fibroids, major uterine malformation (unicorn, septum), Asherman Sd, severe adenomyosis
- Repeated Implantation Failure or Repeated Pregnancy Loss after euploid Single Blastocyst Transfer
- Severe male factor: Abnormal Caryotype or FISH, severe OAT / Cripto-Azoospermia, DNA Fragmentation >50% after medical treatment
- TESE / TESA (testicular sperm extraction/aspiration)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Observational Study to Evaluate the Expression Profiles of Oocyte-potency-related Genes in Cumulus Cells of Women Treated With Human Recombinant FSH (Hr-FSH)and Triggered With GnRH Agonist in an Oocyte Donation Program
This is a randomized observational study. The main aim is to determine potential oocyte competence predictive mRNA expression profiles in the cumulus cells isolated form individual oocytes. In 2 patient cohorts: 1)GnRH Antagonist \& hr-FSH with GnRH Agonist trigger, 2) Progesterone \& hr-FSH with GnRH Agonist trigger.
- Conditions
- Infertility
- Being tested
- AURORA-Donor
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AURORA-DonorOther
Explorative study of cumulus cells gene expression in relation to the oocyte competence for good quality blastocyst formation and predictive for clinical pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| GnRH Antagonist & hr-FSH | Patients stimulated with GnRH Antagonist \& hr-FSH with GnRH Agonist trigger Receives: Other: AURORA-Donor | |
| Progesterone & hr-FSH | Patients stimulated with Progesterone \& hr-FSH with GnRH Agonist trigger Receives: Other: AURORA-Donor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Basic clinical donor patient and stimulation characteristics: P4
Serum values for P4 (ng/ml)
Measured: During ovarian stimulation (max 3 weeks)
Basic clinical donor patient and stimulation characteristics: E2
Serum values for E2 (ng/L)
Measured: During ovarian stimulation (max 3 weeks)
Basic clinical donor patient and stimulation characteristics: Gonadotropin type and dose
Gonadotropin type and dose (IU) used for stimulation
Measured: During ovarian stimulation (max 3 weeks)
Clinical evaluation: number of Follicles
The number of follicles at time of trigger (oocyte-pick-up day-2)
Measured: During ovarian stimulation (max 3 weeks)
Clinical evaluation: number of cumulus-oocyte complex
The number of cumulus-oocyte complex at time of pick-up
Measured: Day 1 of embryo culture
Clinical evaluation: Meiosis II oocytes
The number of meiosis II oocytes (nominator) divided by the total number of oocytes retrieved (denominator)
Measured: Day 1 of embryo culture
Clinical evaluation: Abnormal fertilization
The number of abnormal fertilized oocytes on day 1 at 17+1h post insemination, as a function of all COC's inseminated
Measured: Day 1 of embryo culture
Clinical evaluation: Normal Fertilization
The number of fertilized oocytes on day 1 (presence of 2PN and 2PB assessed at 17 + 1h post-insemination), as a function of all COC's inseminate
Measured: Day 1 of embryo culture
Clinical evaluation: Day 3 embryo evaluation
Day 3 embryo morphology evaluation according to the standard of care of the ART clinic
Measured: Day 3 of embryo culture
Clinical evaluation: Day 5/6 embryo evaluation
Day 5/6 embryo evaluation based on the criteria of Gardner and Schoolcraft (Gardner and Schoolcraft 1999)
Measured: Day 6 of embryo culture
Clinical evaluation: Day5/6 good quality blastocyst rate
Defined as the proportion of 2PN zygotes which are good-quality blastocyst on Day 5/6 (116 +-2h and 140 +-2h post-insemination) (ESHRE Special Interest Group of Embryology and Alpha Scientists in Reproductive Medicine 2017)
Measured: Day 6 of embryo culture
Clinical evaluation: Embryo utilization
Defined as the number of blastocyst suitable for cryopreservation and transfer as a function of the number of normally fertilized (2PN) oocytes observed on day 1 (ESHRE Special Interest Group Alpha Scientists 2017)
Measured: Day 6 of embryo culture
Expression profile: blastocyst formation
The expression profiles of cumulus of oocyte leading to a blastocyst and the expression profiles of cumulus of oocyte not leading to a blastocyst has been determined using RNA-Seq.
Measured: 2.5 years after study start
Secondary outcomes (4)
Biochemical pregnancy
A pregnancy diagnosed only by the detection of beta human chorionic gonadotropin (hCG) in serum or urine
Measured: Day 10 after embryo transfer
Clinical pregnancy with positive fetal heartbeat
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
Expression profile: pregnancy prediction
The expression profile of cumulus of oocytes leading to pregnancy and the expression profiles of oocytes not leading to pregnancy are established using RNA seq.
Measured: 2.5 years after study start
Normalized messenger ribonucleic acid (mRNA) expression
Quantitative Polymerase Chain Reaction (QPCR) data of samples informative for blastocyst formation and pregnancy prediction have been collected
Measured: 2.5 years after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start16 Feb 2024
- Primary completionApr 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fertiga, Belgium
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fertilab, Ferring Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280677
- Sponsor's protocol ID
- 2023.Aurora-Donor
- Status last verified
- Oct 2026
- First submitted
- 31 Jan 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Evaluate the Expression Profiles of Oocyte-potency-related Genes in Cumulus Cells of Women Treated With Human Recombinant FSH (Hr-FSH)and Triggered With GnRH Agonist in an Oocyte Donation Program
- ClinicalTrials.gov ID
- NCT06280677
- Acronym / sponsor ID
- 2023.Aurora-Donor
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Fertiga, BelgiumIndustry (pharma, biotech, devices)
- Collaborators
- Fertilab, Ferring Pharmaceuticals
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 28 Feb 2024 (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 a randomized observational study. The main aim is to determine potential oocyte competence predictive mRNA expression profiles in the cumulus cells isolated form individual oocytes. In 2 patient cohorts: 1)GnRH Antagonist \& hr-FSH with GnRH Agonist trigger, 2) Progesterone \& hr-FSH with GnRH Agonist trigger.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GnRH Antagonist & hr-FSH | – | Other: AURORA-DonorPatients stimulated with GnRH Antagonist \& hr-FSH with GnRH Agonist trigger |
| Progesterone & hr-FSH | – | Other: AURORA-DonorPatients stimulated with Progesterone \& hr-FSH with GnRH Agonist trigger |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Donor's for this study must be between 18 and 35 years of age, and compliant with SEF directive for egg donation. Only patient with at least 6 MII will be included in the study.
Key inclusion criteria (11 listed)
- Patients are 18 to 35 years old
- BMI between 17-30
- Regular menstrual cycles
- AFC > 8
- Patient profile in compliance with SEF (Sociedad Española de Fertilidad) directives for egg donation (medical, psychological and genetic screening, informed consent)
Key exclusion criteria (12 listed)
- BMI < 17 or > 30
- Extreme irregular menstrual cycles (<20 days or >40 days)
- AFC < 8
- <8 MII on previous egg retrieval
- Women with history of poor oocyte maturation or known maturation defect or unexplained failure in previous treatments
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-DonorExplorative study of cumulus cells gene expression in relation to the oocyte competence for good quality blastocyst formation and predictive for clinical pregnancy. | Other | GnRH Antagonist & hr-FSH, Progesterone & hr-FSH |
Primary outcome
Basic clinical donor patient and stimulation characteristics: P4
Time frame: During ovarian stimulation (max 3 weeks)
Serum values for P4 (ng/ml)
Basic clinical donor patient and stimulation characteristics: E2
Time frame: During ovarian stimulation (max 3 weeks)
Serum values for E2 (ng/L)
Basic clinical donor patient and stimulation characteristics: Gonadotropin type and dose
Time frame: During ovarian stimulation (max 3 weeks)
Gonadotropin type and dose (IU) used for stimulation
Clinical evaluation: number of Follicles
Time frame: During ovarian stimulation (max 3 weeks)
The number of follicles at time of trigger (oocyte-pick-up day-2)
Clinical evaluation: number of cumulus-oocyte complex
Time frame: Day 1 of embryo culture
The number of cumulus-oocyte complex at time of pick-up
Clinical evaluation: Meiosis II oocytes
Time frame: Day 1 of embryo culture
The number of meiosis II oocytes (nominator) divided by the total number of oocytes retrieved (denominator)
Clinical evaluation: Abnormal fertilization
Time frame: Day 1 of embryo culture
The number of abnormal fertilized oocytes on day 1 at 17+1h post insemination, as a function of all COC's inseminated
Clinical evaluation: Normal Fertilization
Time frame: Day 1 of embryo culture
The number of fertilized oocytes on day 1 (presence of 2PN and 2PB assessed at 17 + 1h post-insemination), as a function of all COC's inseminate
Clinical evaluation: Day 3 embryo evaluation
Time frame: Day 3 of embryo culture
Day 3 embryo morphology evaluation according to the standard of care of the ART clinic
Clinical evaluation: Day 5/6 embryo evaluation
Time frame: Day 6 of embryo culture
Day 5/6 embryo evaluation based on the criteria of Gardner and Schoolcraft (Gardner and Schoolcraft 1999)
Clinical evaluation: Day5/6 good quality blastocyst rate
Time frame: Day 6 of embryo culture
Defined as the proportion of 2PN zygotes which are good-quality blastocyst on Day 5/6 (116 +-2h and 140 +-2h post-insemination) (ESHRE Special Interest Group of Embryology and Alpha Scientists in Reproductive Medicine 2017)
Clinical evaluation: Embryo utilization
Time frame: Day 6 of embryo culture
Defined as the number of blastocyst suitable for cryopreservation and transfer as a function of the number of normally fertilized (2PN) oocytes observed on day 1 (ESHRE Special Interest Group Alpha Scientists 2017)
Expression profile: blastocyst formation
Time frame: 2.5 years after study start
The expression profiles of cumulus of oocyte leading to a blastocyst and the expression profiles of cumulus of oocyte not leading to a blastocyst has been determined using RNA-Seq.
4 secondary outcomes
Biochemical pregnancy
Time frame: Day 10 after embryo transfer
Clinical pregnancy with positive fetal heartbeat
Time frame: week 5-6 after embryo transfer
Expression profile: pregnancy prediction
Time frame: 2.5 years after study start
Normalized messenger ribonucleic acid (mRNA) expression
Time frame: 2.5 years after study start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- 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.
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 Spain.
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 11 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tom Adriaenssens, PhD (024774645, tom.adriaenssens@fertiga.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Basic clinical donor patient and stimulation characteristics: P4 (time frame: During ovarian stimulation (max 3 weeks)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.