An observational study in Infertility, sponsored by Fertiga, Belgium. Recruiting at 1 site in Spain. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-11.
Sponsored by Fertiga, Belgium · Observational
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's planned enrollment of 160 is below the median of 200 across 714 observational studies indexed under Infertility.
Browse Infertility studies →Fertiga, Belgium is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria Donor:
Exclusion Criteria Donor:
Inclusion Criteria Recipient:
Exclusion Criteria for oocyte Recipients
Patients stimulated with GnRH Antagonist \& hr-FSH with GnRH Agonist trigger
Other: AURORA-Donor
Patients stimulated with Progesterone \& hr-FSH with GnRH Agonist trigger
Other: 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.
Basic clinical donor patient and stimulation characteristics: P4
Serum values for P4 (ng/ml)
Time frame: During ovarian stimulation (max 3 weeks)
Basic clinical donor patient and stimulation characteristics: E2
Serum values for E2 (ng/L)
Time frame: During ovarian stimulation (max 3 weeks)
Basic clinical donor patient and stimulation characteristics: Gonadotropin type and dose
Gonadotropin type and dose (IU) used for stimulation
Time frame: During ovarian stimulation (max 3 weeks)
Clinical evaluation: number of Follicles
The number of follicles at time of trigger (oocyte-pick-up day-2)
Time frame: During ovarian stimulation (max 3 weeks)
Clinical evaluation: number of cumulus-oocyte complex
The number of cumulus-oocyte complex at time of pick-up
Time frame: Day 1 of embryo culture
Clinical evaluation: Meiosis II oocytes
The number of meiosis II oocytes (nominator) divided by the total number of oocytes retrieved (denominator)
Time frame: Day 1 of embryo culture
Clinical evaluation: Abnormal fertilization
The number of abnormal fertilized oocytes on day 1 at 17+1h post insemination, as a function of all COC's inseminated
Time frame: Day 1 of embryo culture
Clinical evaluation: Normal Fertilization
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
Time frame: Day 1 of embryo culture
Clinical evaluation: Day 3 embryo evaluation
Day 3 embryo morphology evaluation according to the standard of care of the ART clinic
Time frame: Day 3 of embryo culture
Clinical evaluation: Day 5/6 embryo evaluation
Day 5/6 embryo evaluation based on the criteria of Gardner and Schoolcraft (Gardner and Schoolcraft 1999)
Time frame: Day 6 of embryo culture
Clinical evaluation: Day5/6 good quality blastocyst rate
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)
Time frame: Day 6 of embryo culture
Clinical evaluation: Embryo utilization
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)
Time frame: Day 6 of embryo culture
Expression profile: blastocyst formation
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.
Time frame: 2.5 years after study start
Biochemical pregnancy
A pregnancy diagnosed only by the detection of beta human chorionic gonadotropin (hCG) in serum or urine
Time frame: Day 10 after embryo transfer
Clinical pregnancy with positive fetal heartbeat
Pregnancy diagnosed by ultrasonographic or clinical documentation of at least one fetus with a discernible heartbeat in gestational week 6 to 8
Time frame: week 5-6 after embryo transfer
Expression profile: pregnancy prediction
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.
Time frame: 2.5 years after study start
Normalized messenger ribonucleic acid (mRNA) expression
Quantitative Polymerase Chain Reaction (QPCR) data of samples informative for blastocyst formation and pregnancy prediction have been collected
Time frame: 2.5 years after study start
Ongoing pregnancy rate
The presence of gestational sacs with fetal heart beat detected by transvaginal ultrasound examination in gestational week 10 to 11
Time frame: Week 10-11 after embryo transfer
Live birth
is defined as the birth of at least one newborn after 24 weeks gestation that exhibits any sign of live (twins will be a single count)
Time frame: week 24-42 after embryo transfer
Cumulative pregnancy
The accumulated ongoing pregnancy after fresh and frozen-warmed embryo transfers within one stimulation cycle. Pregnancy with detectable heart rate at ≥ 12 weeks gestation after the completion of the first transfer. Live birth is defined as the birth of at least one newborn after 24 weeks gestation that exhibits any sign of live (twins will be a single count)
Time frame: 2.5 years after study start
Cumulative live birth
The number of deliveries with at least one live birth resulting from one initiated or aspirated ART cycle, including all cycles in which fresh and/or frozen embryos are transferred, until one delivery with a live birth occurs or until all embryos are used, whichever occurs first.
Time frame: 2.5 years after study start
Miscarriage rate
the spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age
Time frame: week 22 after embryo transfer
Plan to share: No
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Fertiga, Belgium