Aurora Test for ART Donor Patients (AURORA-Donor)

NCT06280677 | Recruiting

• 1 other identifier: 2023.Aurora-Donor
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (13)

• Basic clinical donor patient and stimulation characteristics: P4

  Serum values for P4 (ng/ml)

  During ovarian stimulation (max 3 weeks)

• Basic clinical donor patient and stimulation characteristics: E2

  Serum values for E2 (ng/L)

  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

  During ovarian stimulation (max 3 weeks)

• Clinical evaluation: number of Follicles

  The number of follicles at time of trigger (oocyte-pick-up day-2)

  During ovarian stimulation (max 3 weeks)

• Clinical evaluation: number of cumulus-oocyte complex

  The number of cumulus-oocyte complex at time of pick-up

  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)

  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

  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

  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

  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)

  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)

  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)

  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.

  2.5 years after study start

Secondary Outcomes (4)

• Biochemical pregnancy

  Day 10 after embryo transfer

• Clinical pregnancy with positive fetal heartbeat

  week 5-6 after embryo transfer

• Expression profile: pregnancy prediction

  2.5 years after study start

• Normalized messenger ribonucleic acid (mRNA) expression

  2.5 years after study start

Other Outcomes (5)

• Ongoing pregnancy rate

  Week 10-11 after embryo transfer

• Live birth

  week 24-42 after embryo transfer

• Cumulative pregnancy

  2.5 years after study start

Study Arms (2)

GnRH Antagonist & hr-FSH

Patients stimulated with GnRH Antagonist \& hr-FSH with GnRH Agonist trigger

Other: AURORA-Donor

Progesterone & hr-FSH

Patients stimulated with Progesterone \& hr-FSH with GnRH Agonist trigger

Other: AURORA-Donor

Interventions

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.

GnRH Antagonist & hr-FSH; Progesterone & hr-FSH

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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
• 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

Sponsors & Collaborators

• Fertiga, Belgium: lead
• Fertilab: collaborator
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Fertilab

Barcelona, 08017, Spain

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Tom Adriaenssens, PhD

CONTACT

024774645; tom.adriaenssens@fertiga.com

Study Design

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

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 28, 2024
• Study Start: February 16, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)