Aurora Test for ART Donor Patients (AURORA-Donor)

NCT ID: NCT06280677

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-16

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GnRH Antagonist & hr-FSH

Patients stimulated with GnRH Antagonist \& hr-FSH with GnRH Agonist trigger

AURORA-Donor

Intervention Type OTHER

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

Progesterone & hr-FSH

Patients stimulated with Progesterone \& hr-FSH with GnRH Agonist trigger

AURORA-Donor

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fertilab

UNKNOWN

Sponsor Role collaborator

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Fertiga, Belgium

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fertilab

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Tom Adriaenssens, PhD

Role: CONTACT

024774645

Other Identifiers

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2023.Aurora-Donor

Identifier Type: -

Identifier Source: org_study_id

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