Aurora Test for ART Donor Patients (AURORA-Donor)

Recruiting

• Conditions: Infertility
• Interventions: Other: AURORA-Donor

• Registration Number: NCT06280677
• Lead Sponsor: Fertiga, Belgium

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-31
• Status Verified: 2024-02
• Study Start: 2024-02-16
• Study First Submitted QC: 2024-02-23
• Last Update Submitted: 2024-02-23
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Primary Completion: 2025-04
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Progesterone & hr-FSH	AURORA-Donor	Patients stimulated with Progesterone \& hr-FSH with GnRH Agonist trigger
GnRH Antagonist & hr-FSH	AURORA-Donor	Patients stimulated with GnRH Antagonist \& hr-FSH with GnRH Agonist trigger

Primary Outcome Measures

Name	Time	Method
Clinical evaluation: Day 3 embryo evaluation	Day 3 of embryo culture	Day 3 embryo morphology evaluation according to the standard of care of the ART clinic
Clinical evaluation: number of cumulus-oocyte complex	Day 1 of embryo culture	The number of cumulus-oocyte complex at time of pick-up
Clinical evaluation: Meiosis II oocytes	Day 1 of embryo culture	The number of meiosis II oocytes (nominator) divided by the total number of oocytes retrieved (denominator)
Clinical evaluation: Abnormal fertilization	Day 1 of embryo culture	The number of abnormal fertilized oocytes on day 1 at 17+1h post insemination, as a function of all COC's inseminated
Expression profile: blastocyst formation	2.5 years after study start	The expression profiles of cumulus of oocyte leading to a blastocyst and the expression profiles of cumulus of oocyte not leading to a blastocyst has been determined using RNA-Seq.
Clinical evaluation: Normal Fertilization	Day 1 of embryo culture	The number of fertilized oocytes on day 1 (presence of 2PN and 2PB assessed at 17 + 1h post-insemination), as a function of all COC's inseminate
Basic clinical donor patient and stimulation characteristics: P4	During ovarian stimulation (max 3 weeks)	Serum values for P4 (ng/ml)
Clinical evaluation: Day 5/6 embryo evaluation	Day 6 of embryo culture	Day 5/6 embryo evaluation based on the criteria of Gardner and Schoolcraft (Gardner and Schoolcraft 1999)
Basic clinical donor patient and stimulation characteristics: Gonadotropin type and dose	During ovarian stimulation (max 3 weeks)	Gonadotropin type and dose (IU) used for stimulation
Clinical evaluation: number of Follicles	During ovarian stimulation (max 3 weeks)	The number of follicles at time of trigger (oocyte-pick-up day-2)
Basic clinical donor patient and stimulation characteristics: E2	During ovarian stimulation (max 3 weeks)	Serum values for E2 (ng/L)
Clinical evaluation: Embryo utilization	Day 6 of embryo culture	Defined as the number of blastocyst suitable for cryopreservation and transfer as a function of the number of normally fertilized (2PN) oocytes observed on day 1 (ESHRE Special Interest Group Alpha Scientists 2017)
Clinical evaluation: Day5/6 good quality blastocyst rate	Day 6 of embryo culture	Defined as the proportion of 2PN zygotes which are good-quality blastocyst on Day 5/6 (116 +-2h and 140 +-2h post-insemination) (ESHRE Special Interest Group of Embryology and Alpha Scientists in Reproductive Medicine 2017)

Secondary Outcome Measures

Name	Time	Method
Normalized messenger ribonucleic acid (mRNA) expression	2.5 years after study start	Quantitative Polymerase Chain Reaction (QPCR) data of samples informative for blastocyst formation and pregnancy prediction have been collected
Biochemical pregnancy	Day 10 after embryo transfer	A pregnancy diagnosed only by the detection of beta human chorionic gonadotropin (hCG) in serum or urine
Expression profile: pregnancy prediction	2.5 years after study start	The expression profile of cumulus of oocytes leading to pregnancy and the expression profiles of oocytes not leading to pregnancy are established using RNA seq.
Clinical pregnancy with positive fetal heartbeat	week 5-6 after embryo transfer	Pregnancy diagnosed by ultrasonographic or clinical documentation of at least one fetus with a discernible heartbeat in gestational week 6 to 8

Trial Locations

Locations (1)

Fertilab; 🇪🇸 Barcelona, Spain