Menu
Recruiting NCT06280677

Aurora Test for ART Donor Patients (AURORA-Donor)

— Observational Infertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AURORA-Donor.
Who it may be relevant to
Registry conditions: Infertility. Basic parameters: 18 years — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Basic clinical donor patient and stimulation characteristics: P4 [Time frame: During ovarian stimulation (max 3 weeks)]
  • Basic clinical donor patient and stimulation characteristics: E2 [Time frame: During ovarian stimulation (max 3 weeks)]
  • Basic clinical donor patient and stimulation characteristics: Gonadotropin type and dose [Time frame: During ovarian stimulation (max 3 weeks)]
  • Clinical evaluation: number of Follicles [Time frame: During ovarian stimulation (max 3 weeks)]
  • Clinical evaluation: number of cumulus-oocyte complex [Time frame: Day 1 of embryo culture]
  • Clinical evaluation: Meiosis II oocytes [Time frame: Day 1 of embryo culture]
  • Clinical evaluation: Abnormal fertilization [Time frame: Day 1 of embryo culture]
  • Clinical evaluation: Normal Fertilization [Time frame: Day 1 of embryo culture]
  • Clinical evaluation: Day 3 embryo evaluation [Time frame: Day 3 of embryo culture]
  • Clinical evaluation: Day 5/6 embryo evaluation [Time frame: Day 6 of embryo culture]
Secondary outcome measures (4)
  • Biochemical pregnancy [Time frame: Day 10 after embryo transfer]
  • Clinical pregnancy with positive fetal heartbeat [Time frame: week 5-6 after embryo transfer]
  • Expression profile: pregnancy prediction [Time frame: 2.5 years after study start]
  • Normalized messenger ribonucleic acid (mRNA) expression [Time frame: 2.5 years after study start]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Fertilab — Barcelona

Identifiers

NCT: NCT06280677 · 2023.Aurora-Donor

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗