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

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

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

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Drug: r-hFSH

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.

• Study Type: Observational
• Enrollment (Actual): 1195

Contacts and Locations

Study Locations

• Germany
  • Lower Saxony
    • Oldenburg, Lower Saxony, Germany, 26121
      • Team Kinderwunsch Oldenburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Finox AG
• Investigators: Principal Investigator: Jan-Steffen Krüssel, MD, Leiter universitäres interdisziplinäres Kinderwunschzentrum Düsseldorf (UniKiD)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: October 20, 2016
• First Submitted That Met QC Criteria: October 21, 2016
• First Posted (Estimate): October 24, 2016

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Pregnancy; r-hFSH; OHSS; Bemfola; Oocytes
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: FIN-BEM-2016-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided