Infertility Clinical Trial
Official title:
Prospective Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Technology
Verified date | February 2020 |
Source | Finox AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Prospective, non-comparative, multi-centre, multi-country, observational post-authorization study, to correlate predictive factors with number of oocytes in relation to the gonadotropin dose administered using a new r-hFSH product (Bemfola®) for ovarian stimulation and GnRH-antagonists for pituitary suppression
Status | Completed |
Enrollment | 1195 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Female subject justifying an IVF/ICSI treatment - Age over 18 years (inclusive) at the time of the screening visit - Signed informed patient consent - Received only Bemfola® for ovarian stimulation - Pituitary suppression with GnRH-antagonists Exclusion Criteria: - Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients - Tumours of the hypothalamus or pituitary gland - Ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome - Gynaecological haemorrhages of unknown aetiology - Ovarian, uterine or mammary carcinoma |
Country | Name | City | State |
---|---|---|---|
Germany | Team Kinderwunsch Oldenburg | Oldenburg | Lower Saxony |
Lead Sponsor | Collaborator |
---|---|
Finox AG |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of oocytes retrieved | 34-36 hours after hCG administration | ||
Secondary | Antral Follicle Count (AFC) | Day 1 | ||
Secondary | Basal FSH level | Day 1 | ||
Secondary | r-hFSH dose on first and last day of stimulation | Day 1 of stimulation through to maximum Day 16 of stimulation | ||
Secondary | Days of FSH stimulation (with r-hFSH daily doses) | Day 1 of stimulation through to maximum Day 16 of stimulation | ||
Secondary | r-hFSH total dose | Day 1 of stimulation through to maximum Day 16 of stimulation | ||
Secondary | Type of oocyte trigger (ß-hCG / GnRH agonist) | At Day of hCG administration | ||
Secondary | Number of oocytes fertilized (classified as 2PN stages) | Day 1,2,3 or 5 after ovum pick-up/fertilisation | ||
Secondary | Number of 2PN cells cryopreserved | Day 1,2,3 or 5 after ovum pick-up/fertilisation | ||
Secondary | Number of embryos transferred | Day 2-5 after ovum pick-up | ||
Secondary | Proportion of Biochemical pregnancies (determined by serum B-hCG levels) | 15-20 days after oocyte retrieval | ||
Secondary | Implantation rate (gestational sacs with heartbeat per total number of embryos transferred) | 15-20 days after oocyte retrieval | ||
Secondary | Incidence of Ovarian Hyper-Stimulation Syndrome (OHSS), classified as mild, moderate and severe | From Day 1 of stimulation | ||
Secondary | Incidence of ALL other Treatment-Emergent Adverse Events | From Day 1 of study period | ||
Secondary | Proportion of clinical pregnancies (determined by the presence of a gestational sac) | 35-42 days after oocyte retrieval |
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