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Non-comparative, observational, ambispective post-authorisation study (EPA-SP).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| r-hFSH | Drug | As per standard practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total number of oocytes retrieved | 34-36 hours after hCG administration and after a maximum 16 days of r-hFSH treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of fertilised oocytes | 1 day after ovum pick-up | |
| Quality of oocytes | At Day 4-5 | |
| Number and quality of transferred embryos |
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Inclusion Criteria:
Exclusion Criteria:
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Women who have undergone oocyte retrieval after ovarian stimulation with Bemfola®, either as part of an in vitro fertilisation (IVF) cycle or with an intracytoplasmic sperm injection (ICSI), for reproductive purposes or for oocyte donation, and who are pituitary-suppressed with a GnRH antagonist.
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| Name | Affiliation | Role |
|---|---|---|
| Marcos Ferrando, MD | Director IVI Bilbao, Spain | Principal Investigator |
| Buenaventura Coroleu Lletget, MD | Jefe del Servicio de Medicina de la Reproducción,Hospital Universitari Quirón Dexeus, Barcelona, Spain | Principal Investigator |
| Luis RodrÃguez-Tabernero MartÃn, MD | Jefe de la Unidad de Reproducción, Hospital ClÃnico Universitario de Valladolid, Valladolid, Spai^n | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IVI Barcelona | Barcelona | 08017 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32742711 | Derived | Ferrando M, Coroleu B, Rodriguez-Tabernero L, Barrenetxea G, Guix C, Sanchez F, Jenkins J; BIRTH study group. The continuum of ovarian response leading to BIRTH, a real world study of ART in Spain. Fertil Res Pract. 2020 Jul 29;6:13. doi: 10.1186/s40738-020-00081-4. eCollection 2020. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Day of embryo transfer, either 2,3 or 5 days after oocyte retrieval |
| Fertilization and implantation rate | 5 to 6 weeks after oocyte retrieval |
| Incidence of serious adverse events, including moderate-to-severe OHSS | From Day 1 of stimulation |