Clinical trial NCT06280677: Aurora Test for ART Donor Patients (AURORA-Donor)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility
Lead sponsor: Fertiga, Belgium
Sponsor class: INDUSTRY
Collaborators: name: Fertilab
name: Ferring Pharmaceuticals
First posted: 2024-02-28
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Donor's for this study must be between 18 and 35 years of age, and compliant with SEF directive for egg donation. Only patient with at least 6 MII will be included in the study.

Brief 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 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)

Primary outcomes:
measure: Basic clinical donor patient and stimulation characteristics: P4
timeFrame: During ovarian stimulation (max 3 weeks)
measure: Basic clinical donor patient and stimulation characteristics: E2
timeFrame: During ovarian stimulation (max 3 weeks)
measure: Basic clinical donor patient and stimulation characteristics: Gonadotropin type and dose
timeFrame: During ovarian stimulation (max 3 weeks)
measure: Clinical evaluation: number of Follicles
timeFrame: During ovarian stimulation (max 3 weeks)
measure: Clinical evaluation: number of cumulus-oocyte complex
timeFrame: Day 1 of embryo culture
measure: Clinical evaluation: Meiosis II oocytes
timeFrame: Day 1 of embryo culture
measure: Clinical evaluation: Abnormal fertilization
timeFrame: Day 1 of embryo culture
measure: Clinical evaluation: Normal Fertilization
timeFrame: Day 1 of embryo culture
measure: Clinical evaluation: Day 3 embryo evaluation
timeFrame: Day 3 of embryo culture
measure: Clinical evaluation: Day 5/6 embryo evaluation
timeFrame: Day 6 of embryo culture
measure: Clinical evaluation: Day5/6 good quality blastocyst rate
timeFrame: Day 6 of embryo culture
measure: Clinical evaluation: Embryo utilization
timeFrame: Day 6 of embryo culture
measure: Expression profile: blastocyst formation
timeFrame: 2.5 years after study start
Secondary outcomes:
measure: Biochemical pregnancy
timeFrame: Day 10 after embryo transfer
measure: Clinical pregnancy with positive fetal heartbeat
timeFrame: week 5-6 after embryo transfer
measure: Expression profile: pregnancy prediction
timeFrame: 2.5 years after study start
measure: Normalized messenger ribonucleic acid (mRNA) expression
timeFrame: 2.5 years after study start
Other outcomes:
measure: Ongoing pregnancy rate
timeFrame: Week 10-11 after embryo transfer
measure: Live birth
timeFrame: week 24-42 after embryo transfer
measure: Cumulative pregnancy
timeFrame: 2.5 years after study start
measure: Cumulative live birth
timeFrame: 2.5 years after study start
measure: Miscarriage rate
timeFrame: week 22 after embryo transfer
Locations:
city: Barcelona
country: Spain
facility: Fertilab
Study officials:
References: