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

Completed

• Conditions: Infertility

• Registration Number: NCT02942849
• Lead Sponsor: Finox AG

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-20
• Study First Submitted QC: 2016-10-21
• Study First Posted: 2016-10-24
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1195

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of oocytes retrieved	34-36 hours after hCG administration

Secondary Outcome Measures

Name	Time	Method
Proportion of clinical pregnancies (determined by the presence of a gestational sac)	35-42 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
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
Number of embryos transferred	Day 2-5 after ovum pick-up
Antral Follicle Count (AFC)	Day 1
r-hFSH total dose	Day 1 of stimulation through to maximum Day 16 of stimulation
Number of oocytes fertilized (classified as 2PN stages)	Day 1,2,3 or 5 after ovum pick-up/fertilisation
Proportion of Biochemical pregnancies (determined by serum B-hCG levels)	15-20 days after oocyte retrieval
Type of oocyte trigger (ß-hCG / GnRH agonist)	At Day of hCG administration
Number of 2PN cells cryopreserved	Day 1,2,3 or 5 after ovum pick-up/fertilisation
Implantation rate (gestational sacs with heartbeat per total number of embryos transferred)	15-20 days after oocyte retrieval

Trial Locations

Locations (1)

Team Kinderwunsch Oldenburg; 🇩🇪 Oldenburg, Lower Saxony, Germany