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| Name | Class |
|---|---|
| Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | INDUSTRY |
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This is an observational study. The main aim is to determine the expression of potential biomarker genes in the cumulus cells isolated from individual oocytes in two patient cohorts: recombinant human Follicle Stimulating Hormone(hFSH) and recombinant hFSH:human Luteinizing Hormone(r-hLH) ratio 2:1. Algorithms from gene combinations will be identified that predict embryo quality and pregnancy outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| recombinant hFSH | Patient stimulated with recombinant hFSH |
| |
| recombinant hFSH : r-hLH | Patient stimulated with recombinant hFSH : r-hLH ratio 2:1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AURORA-Rec | Other | Explorative study of cumulus cells gene expression in relation to the patient treatment and oocyte competence. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Normalized messenger ribonucleic acid (mRNA) expression | Normalized mRNA levels of biomarker genes that are assessed in cumulus cells by reverse transcription quantitative Polymerase Chain Reaction (RT-qPCR) for each oocyte. | 3 years after study start |
| Measure | Description | Time Frame |
|---|---|---|
| Meiosis II Oocyte rate | The number of meiosis II oocytes (nominator) divided by the total number of oocytes retrieved (denominator) | Day 0 of embryo collection |
| Normal fertilization rate | The number of fertilized oocytes on Day 1 (presence of 2 pronuclei (2PN) and the second polar body (2PB) assessed at 17 ± 1 h postinsemination, as a function of all cumulus-oocytes complexes (COCs) inseminated |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative ongoing pregnancy rate | 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 | 3 years after study start |
| Live Birth rate |
Inclusion Criteria:
Exclusion Criteria:
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Patients for this study must be between 22-38 years of age, have a good ovarian reserve and response, and need to be naïve to IVF/ ICSI or have only one prior ICSI cycle. Only patients with 7-18 follicles at the end of ovarian stimulation will be allowed to enter the study on the day of decision of hCG injection (or the day before). Patients with fewer than 7 oocytes will be excluded from the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Jette | 1090 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41275247 | Derived | Adriaenssens T, Van Vaerenbergh I, Van Leuven W, Coucke W, Montenegro S, Zheng W, D'Hooghe T, Van Landuyt L, De Munck N, Van Hecke E, Smitz J, Rosenthal A, Blockeel C. Live birth in patients stimulated with r-hFSH or r-hFSH: r-hLH is strongly associated with cumulus cell derived gene expression models. Reprod Biol Endocrinol. 2025 Nov 22;23(1):163. doi: 10.1186/s12958-025-01480-2. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Day 1 of embryo culture |
| Day 5 good-quality embryo rate | Defined as the proportion of 2PN zygotes which are good-quality blastocysts on Day 5 | Day 5 of embryo culture |
| Embryo utilization rate | Defined as the number of embryos (or blastocysts) suitable for transfer or cryopreservation as a function of the number of normally fertilized (2PN) oocytes observed on Day 1 | Day 5 of embryo culture |
| Biochemical pregnancy rate | A pregnancy diagnosed only by the detection of beta human chorionic gonadotropin (hCG) in serum or urine | Day 10 after embryo transfer |
| Fetal heart beat positive implantation rate | Rate refers to the proportion of fetal heartbeats detected relative to the number of embryos transferred | Week 5-6 after embryo transfer |
| Clinical pregnancy rate | 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 |
| 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 |
| Miscarriage rate | The spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age. In this study we capture spontaneous miscarriage till gestational week 12. | Week 12 after embryo transfer |
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 Live Birth rate | The number of deliveries with at least one live birth resulting from one initiated or aspirated artificial reproductive technologies (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. | 3 years after study start |