Post-Authorisation Study on the Use of Bemfola® in Human... | NCT02942849

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

NCT02942849

Sponsor

Finox AG

Status

Completed

Last Update Posted

Feb 5, 2020Actual

Enrollment

1,195Actual

Phase

Not provided

Conditions

Infertility

Interventions

r-hFSH

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Dec 2018Actual

Completion Date

Dec 2018Actual

First Submitted Date

Oct 20, 2016

First Submission Date that Met QC Criteria

Oct 21, 2016

First Posted Date

Oct 24, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2020

Last Update Posted Date

Feb 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,195Actual

Name	Type	Description	Arm Group Labels	Other Names
r-hFSH	Drug	As per standard clinical practice		Bemfola

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jan-Steffen Krüssel, MD	Leiter universitäres interdisziplinäres Kinderwunschzentrum Düsseldorf (UniKiD)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Team Kinderwunsch Oldenburg		Oldenburg	Lower Saxony	26121	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases