Aurora Test for ART Donor Patients (AURORA-Donor)

Last updated: August 5, 2025
Sponsor: Fertiga, Belgium
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Treatment

AURORA-Donor

Clinical Study ID

NCT06280677
2023.Aurora-Donor
  • Ages 18-35
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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)

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: AURORA-Donor
Phase:
Study Start date:
February 16, 2024
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Fertilab

    Barcelona, 08017
    Spain

    Active - Recruiting

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