Clinical trial NCT02942849: Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Technology
Official title: Prospective Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Bemfola
r-hFSH
Oocytes
Pregnancy
OHSS
Lead sponsor: Finox AG
Sponsor class: INDUSTRY
First posted: 2016-10-24
Enrollment: 1195
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will comprise 1800 women intending to undergo ovarian stimulation with Bemfola® in order to have follicular puncture and oocyte retrieval performed as part of an in vitro fertilisation cycle with or without intracytoplasmic sperm injection, for reproductive purposes, and who are pituitary-suppressed with a GnRH antagonist.

About 30 Fertility centres will be involved in the study. Upon site initiation, each investigator site will enrol the subjects who meet the inclusion criteria.

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.

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

Primary outcomes:
measure: Number of oocytes retrieved
timeFrame: 34-36 hours after hCG administration
Secondary outcomes:
measure: Antral Follicle Count (AFC)
timeFrame: Day 1
measure: Basal FSH level
timeFrame: Day 1
measure: r-hFSH dose on first and last day of stimulation
timeFrame: Day 1 of stimulation through to maximum Day 16 of stimulation
measure: Days of FSH stimulation (with r-hFSH daily doses)
timeFrame: Day 1 of stimulation through to maximum Day 16 of stimulation
measure: r-hFSH total dose
timeFrame: Day 1 of stimulation through to maximum Day 16 of stimulation
measure: Type of oocyte trigger (ß-hCG / GnRH agonist)
timeFrame: At Day of hCG administration
measure: Number of oocytes fertilized (classified as 2PN stages)
timeFrame: Day 1,2,3 or 5 after ovum pick-up/fertilisation
measure: Number of 2PN cells cryopreserved
timeFrame: Day 1,2,3 or 5 after ovum pick-up/fertilisation
measure: Number of embryos transferred
timeFrame: Day 2-5 after ovum pick-up
measure: Proportion of Biochemical pregnancies (determined by serum B-hCG levels)
timeFrame: 15-20 days after oocyte retrieval
measure: Implantation rate (gestational sacs with heartbeat per total number of embryos transferred)
timeFrame: 15-20 days after oocyte retrieval
measure: Incidence of Ovarian Hyper-Stimulation Syndrome (OHSS), classified as mild, moderate and severe
timeFrame: From Day 1 of stimulation
measure: Incidence of ALL other Treatment-Emergent Adverse Events
timeFrame: From Day 1 of study period
measure: Proportion of clinical pregnancies (determined by the presence of a gestational sac)
timeFrame: 35-42 days after oocyte retrieval
Other outcomes:
Locations:
city: Oldenburg
country: Germany
facility: Team Kinderwunsch Oldenburg
state: Lower Saxony
Study officials:
affiliation: Leiter universitäres interdisziplinäres Kinderwunschzentrum Düsseldorf (UniKiD)
name: Jan-Steffen Krüssel, MD
role: PRINCIPAL_INVESTIGATOR
References: