RecruitingNot Applicable

Aurora Test for ART Donor Patients (AURORA-Donor)

Spain160 participantsStarted 2024-02-16

Plain-language 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.

Who can participate

Age range

18 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 parti…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Basic clinical donor patient and stimulation characteristics: P4

Timeframe: During ovarian stimulation (max 3 weeks)

Basic clinical donor patient and stimulation characteristics: E2

Timeframe: During ovarian stimulation (max 3 weeks)

Basic clinical donor patient and stimulation characteristics: Gonadotropin type and dose

Timeframe: During ovarian stimulation (max 3 weeks)

Clinical evaluation: number of Follicles

Timeframe: During ovarian stimulation (max 3 weeks)

Clinical evaluation: number of cumulus-oocyte complex

Timeframe: Day 1 of embryo culture

Clinical evaluation: Meiosis II oocytes

Timeframe: Day 1 of embryo culture

Clinical evaluation: Abnormal fertilization

Timeframe: Day 1 of embryo culture

Trial details

NCT IDNCT06280677

SponsorFertiga, Belgium

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-04

Contact for this trial

Tom Adriaenssens, PhD

024774645 tom.adriaenssens@fertiga.com

View on ClinicalTrials.gov More Infertility trials

Plain-language summary

Who can participate

Age range

18 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Basic clinical donor patient and stimulation characteristics: P4

Timeframe: During ovarian stimulation (max 3 weeks)

Basic clinical donor patient and stimulation characteristics: E2

Timeframe: During ovarian stimulation (max 3 weeks)

Basic clinical donor patient and stimulation characteristics: Gonadotropin type and dose

Timeframe: During ovarian stimulation (max 3 weeks)

Clinical evaluation: number of Follicles

Timeframe: During ovarian stimulation (max 3 weeks)

Clinical evaluation: number of cumulus-oocyte complex

Timeframe: Day 1 of embryo culture

Clinical evaluation: Meiosis II oocytes

Timeframe: Day 1 of embryo culture

Clinical evaluation: Abnormal fertilization

Timeframe: Day 1 of embryo culture