RecruitingNCT06280677

Aurora Test for ART Donor Patients (AURORA-Donor)

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

Sponsor

Fertiga, Belgium

Enrollment

160 participants

Start Date

Feb 16, 2024

Study Type

OBSERVATIONAL

Conditions

Infertility

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

Sex: FEMALEMin Age: 18 YearsMax Age: 35 Years

Inclusion Criteria11

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
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 Criteria12

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)
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)

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Interventions

OTHERAURORA-Donor

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