Actively Recruiting
An Observational Study to Evaluate Oocyte Gene Expression in Women Treated With Human Recombinant FSH and GnRH Agonist Trigger in an Egg Donation Program
Led by Fertiga, Belgium · Updated on 2025-08-11
160
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
F
Fertiga, Belgium
Lead Sponsor
F
Fertilab
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a randomized observational study to explore gene expression profiles in cumulus cells surrounding oocytes from women undergoing ovarian stimulation. The goal is to identify mRNA markers that predict oocyte competence and potential for forming high-quality blastocysts and achieving clinical pregnancy. The study involves two groups of women treated with different ovarian stimulation protocols using human recombinant FSH and GnRH agonist triggers in an egg donation program. Participants are divided into two cohorts: one receiving GnRH antagonist with hr-FSH and GnRH agonist trigger, and the other receiving progesterone with hr-FSH and GnRH agonist trigger. The study observes gene expression in cumulus cells collected from oocytes after denudation during egg retrieval. This includes an examination of basic stimulation characteristics such as hormone levels, follicle counts, fertilization rates, and embryo quality up to day 6 of embryo culture. During the study, participants undergo ovarian stimulation for up to three weeks with monitoring of hormones like progesterone and estradiol, follicle development, and oocyte maturity. Researchers assess fertilization outcomes and embryo development across several days. The study also measures gene expression profiles and pregnancy outcomes up to 2.5 years after starting. Patient consent for oocyte testing and detailed clinical evaluations are part of the process, with ongoing data collection on pregnancy and blastocyst formation.
CONDITIONS
Brief Title
Aurora Test for ART Donor Patients (AURORA-Donor)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients are 18 to 35 years old
- BMI between 17 and 30
- Regular menstrual cycles
- Antral follicle count (AFC) greater than 8
- Patient profile meets SEF directives for egg donation including medical, psychological, and genetic screening with informed consent
- Patients undergoing stimulation with either GnRH Antagonist and hr-FSH with GnRH Agonist trigger or Progesterone and hr-FSH with GnRH Agonist trigger
- Patients agree to oocyte denudation for cumulus testing and provide written informed consent
You will not qualify if you...
- BMI less than 17 or greater than 30
- Extremely irregular menstrual cycles (less than 20 days or more than 40 days)
- Antral follicle count (AFC) less than 8
- Fewer than 8 mature (Meiosis II) oocytes retrieved in previous cycle
- History of poor oocyte maturation, known maturation defects, or unexplained failure in previous treatments
- Failure to comply with SEF directives for egg donation including medical, psychological, and genetic screening with informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 weeks
Participants undergoing ovarian stimulation are observed while clinical and biochemical characteristics are collected.
Visits during ovarian stimulation period
Duration - 1 week
Participants undergo oocyte retrieval, cumulus cell collection, and embryo culture assessments to evaluate oocyte competence and embryo quality.
Multiple visits including Day 1, Day 3, and Day 6 of embryo culture
Duration - Up to 2.5 years
Participants are followed long-term for gene expression analysis and pregnancy outcomes.
Follow-up visits as applicable for pregnancy evaluation and gene expression profiling
Trial Site Locations
Total: 1 location
1
Fertilab
Barcelona, Spain, 08017
Actively Recruiting
Research Team
T
Tom Adriaenssens, PhD
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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