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| Name | Class |
|---|---|
| Fertilab | UNKNOWN |
| Ferring Pharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GnRH Antagonist & hr-FSH | Patients stimulated with GnRH Antagonist & hr-FSH with GnRH Agonist trigger |
| |
| Progesterone & hr-FSH | Patients stimulated with Progesterone & hr-FSH with GnRH Agonist trigger |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AURORA-Donor | Other | Explorative study of cumulus cells gene expression in relation to the oocyte competence for good quality blastocyst formation and predictive for clinical pregnancy. |
| Measure | Description | Time Frame |
|---|---|---|
| Basic clinical donor patient and stimulation characteristics: P4 | Serum values for P4 (ng/ml) | During ovarian stimulation (max 3 weeks) |
| Basic clinical donor patient and stimulation characteristics: E2 | Serum values for E2 (ng/L) | 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 | During ovarian stimulation (max 3 weeks) |
| Clinical evaluation: number of Follicles | The number of follicles at time of trigger (oocyte-pick-up day-2) | During ovarian stimulation (max 3 weeks) |
| Clinical evaluation: number of cumulus-oocyte complex | The number of cumulus-oocyte complex at time of pick-up | 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) | 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 | Day 1 of embryo culture |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical pregnancy | A pregnancy diagnosed only by the detection of beta human chorionic gonadotropin (hCG) in serum or urine | Day 10 after embryo transfer |
| Clinical pregnancy with positive fetal heartbeat |
| Measure | Description | Time Frame |
|---|---|---|
| Ongoing pregnancy rate | The presence of gestational sacs with fetal heart beat detected by transvaginal ultrasound examination in gestational week 10 to 11 | Week 10-11 after embryo transfer |
| Live birth |
Inclusion Criteria Donor:
Exclusion Criteria Donor:
Inclusion Criteria Recipient:
Exclusion Criteria for oocyte Recipients
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tom Adriaenssens, PhD | Contact | 024774645 | tom.adriaenssens@fertiga.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fertilab | Recruiting | Barcelona | 08017 | Spain |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| 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 | 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 | 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) | 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) | 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) | 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. | 2.5 years after study start |
Pregnancy diagnosed by ultrasonographic or clinical documentation of at least one fetus with a discernible heartbeat in gestational week 6 to 8
| 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. | 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 | 2.5 years after study start |
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)
| 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) | 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. | 2.5 years after study start |
| Miscarriage rate | the spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age | week 22 after embryo transfer |