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NCT Number: NCT06280677

Aurora Test for ART Donor Patients (AURORA-Donor)

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Fertilab

Barcelona, 08017, Spain

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Donor:

  • 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
  • Patients agree that the oocytes will be denuded for cumulus testing and provide written informed consent for participation to the study

Exclusion criteria

Donor:

  • 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)

Inclusion criteria

Recipient:

  • 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

Exclusion criteria

for oocyte Recipients

  • 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)

Treatment and study plan

AURORA-Donor

Other

Explorative study of cumulus cells gene expression in relation to the oocyte competence for good quality blastocyst formation and predictive for clinical pregnancy.

Primary outcomes

  1. Basic clinical donor patient and stimulation characteristics: P4

    Time frame: During ovarian stimulation (max 3 weeks)

    Serum values for P4 (ng/ml)

  2. Basic clinical donor patient and stimulation characteristics: E2

    Time frame: During ovarian stimulation (max 3 weeks)

    Serum values for E2 (ng/L)

  3. 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

  4. 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)

  5. 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

  6. 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)

  7. 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

  8. 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

  9. 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

  10. 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)

  11. 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)

  12. 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)

  13. 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.

Secondary outcomes

  1. Biochemical pregnancy

    Time frame: Day 10 after embryo transfer

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

  2. Clinical pregnancy with positive fetal heartbeat

    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

  3. Expression profile: pregnancy prediction

    Time frame: 2.5 years after study start

    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.

  4. Normalized messenger ribonucleic acid (mRNA) expression

    Time frame: 2.5 years after study start

    Quantitative Polymerase Chain Reaction (QPCR) data of samples informative for blastocyst formation and pregnancy prediction have been collected

Other outcomes

  1. 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

  2. Live birth

    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 pregnancy

    Time frame: 2.5 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.

    Live birth 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)

  4. Cumulative live birth

    Time frame: 2.5 years after study start

    The number of deliveries with at least one live birth resulting from one initiated or aspirated 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.

  5. Miscarriage rate

    Time frame: week 22 after embryo transfer

    the spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age

Study contacts

Contact information is provided by the study sponsor or research team.

Tom Adriaenssens, PhD

CONTACT

[email protected]

024774645

Sponsors and collaborators

Lead sponsor

Fertiga, Belgium

Industry

Collaborators

  • Ferring Pharmaceuticals
  • Fertilab

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2024
Registry last updated
Aug 11, 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.

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