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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02942849
• Other study ID #: FIN-BEM-2016-04
• Status: Completed
• Start date: September 2016
• Est. completion date: December 2018

Study information

• Verified date: February 2020
• Source: Finox AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• r-hFSH
As per standard clinical practice

Locations

Country	Name	City	State
Germany	Team Kinderwunsch Oldenburg	Oldenburg	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Finox AG

Country where clinical trial is conducted

Germany, 

Outcome

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