Actively Recruiting

Age: 18Years - 35Years
FEMALE
Healthy Volunteers
NCT06280677

Aurora Test for ART Donor Patients (AURORA-Donor)

Led by Fertiga, Belgium · Updated on 2025-08-11

160

Participants Needed

1

Research Sites

132 weeks

Total Duration

On this page

Sponsors

F

Fertiga, Belgium

Lead Sponsor

F

Fertilab

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Aurora Test for ART Donor Patients (AURORA-Donor)

Who Can Participate

Age: 18Years - 35Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients are 18 to 35 years old
  • BMI between 17-30
  • Regular menstrual cycles
  • AFC > 8
  • Patient profile complies with SEF directives for egg donation including medical, psychological and genetic screening and informed consent
  • Patients' stimulation with GnRH Antagonist & hr-FSH with GnRH Agonist trigger or Progesterone & hr-FSH with GnRH Agonist trigger
  • Patients agree to oocyte denudation for cumulus testing and provide written informed consent
  • Patients applying for ART egg donation with fresh/frozen sperm from partner or frozen donor sperm using eSB-FET in modified natural or HRT cycle
  • Patients are 18 to 50 years old
  • Patients will be treated by ICSI and eSB-FET
  • Recipient patients agree to oocyte denudation for cumulus testing and provide written informed consent
Not Eligible

You will not qualify if you...

  • BMI < 17 or > 30
  • Extreme irregular menstrual cycles (<20 days or >40 days)
  • AFC < 8
  • Fewer than 8 MII on previous egg retrieval
  • History of poor oocyte maturation, known maturation defect, or unexplained failure in previous treatments
  • Failure to comply with SEF directives for egg donation
  • Patient included in any other prospective study
  • BMI < 17 or > 35
  • Severe uterine factors such as multiple myomectomy, multiple fibroids, major uterine malformation, Asherman syndrome, or severe adenomyosis
  • Repeated implantation failure or repeated pregnancy loss after euploid single blastocyst transfer
  • Severe male factor infertility including abnormal karyotype or FISH, severe oligoasthenoteratozoospermia (OAT), crypto-azoospermia, or DNA fragmentation >50% after medical treatment
  • Use of testicular sperm extraction or aspiration (TESE/TESA)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fertilab

Barcelona, Spain, 08017

Actively Recruiting

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Research Team

T

Tom Adriaenssens, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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