Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Technology

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
This will be a prospective, non-comparative, multi-centre, multi-country, observational post-authorization study in Germany and Austria. The study will evaluate the use of follitropin alfa (Bemfola®) in controlled ovarian stimulation for IVF/ICSI. About 30 ART centres will be involved in the study. Upon site initiation, each investigator site will enrol the subjects who meet the inclusion criteria. As this is an observational study, there will be no additional treatment or diagnostic procedures performed on subjects other than those of the investigators' local routine clinical practice. The decision to start ART treatment and to use Bemfola® in controlled ovarian hyperstimulation (COH) following a GnRH antagonist protocol will be made independently by the investigators as per the ART centre's protocol, preceding patient enrollment for this study.

Official Title
-----------------
Prospective Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Technology

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: r-hFSH


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: r-hFSH|As per standard clinical practice|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes retrieved |  | 34-36 hours after hCG administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antral Follicle Count (AFC) |  | Day 1 | 
| Basal FSH level |  | Day 1 | 
| r-hFSH dose on first and last day of stimulation |  | Day 1 of stimulation through to maximum Day 16 of stimulation | 
| Days of FSH stimulation (with r-hFSH daily doses) |  | Day 1 of stimulation through to maximum Day 16 of stimulation | 
| r-hFSH total dose |  | Day 1 of stimulation through to maximum Day 16 of stimulation | 
| Type of oocyte trigger (ß-hCG / GnRH agonist) |  | At Day of hCG administration | 
| Number of oocytes fertilized (classified as 2PN stages) |  | Day 1,2,3 or 5 after ovum pick-up/fertilisation | 
| Number of 2PN cells cryopreserved |  | Day 1,2,3 or 5 after ovum pick-up/fertilisation | 
| Number of embryos transferred |  | Day 2-5 after ovum pick-up | 
| Proportion of Biochemical pregnancies (determined by serum B-hCG levels) |  | 15-20 days after oocyte retrieval | 
| Implantation rate (gestational sacs with heartbeat per total number of embryos transferred) |  | 15-20 days after oocyte retrieval | 
| Incidence of Ovarian Hyper-Stimulation Syndrome (OHSS), classified as mild, moderate and severe |  | From Day 1 of stimulation | 
| Incidence of ALL other Treatment-Emergent Adverse Events |  | From Day 1 of study period | 
| Proportion of clinical pregnancies (determined by the presence of a gestational sac) |  | 35-42 days after oocyte retrieval | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bemfola, r-hFSH, Oocytes, Pregnancy, OHSS