Aurora Test for ART Donor Patients (AURORA-Donor)

Launched by FERTIGA, BELGIUM · Feb 23, 2024

Keywords

ClinConnect Summary

The AURORA-Donor trial is studying how certain markers in the cells surrounding eggs (called cumulus cells) can predict the quality of those eggs in women who are donating them for fertility treatments. This research involves two groups of women who are undergoing specific types of hormone treatments to stimulate egg production. The goal is to understand better which eggs are more likely to lead to successful pregnancies, helping future parents struggling with infertility.

To participate in this trial, donor women need to be between 18 and 35 years old, have a healthy body weight, regular menstrual cycles, and a certain number of follicles in their ovaries. They will be required to agree to have their eggs tested and provide written consent to participate. Recipients of the donated eggs, who are typically women aged 18 to 50 undergoing assisted reproductive technology, will also need to consent to the testing process. Participants can expect to receive comprehensive care and monitoring during the study, which aims to improve outcomes for families seeking help with infertility.

Gender

FEMALE

Eligibility criteria

• 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)