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

NCT02942849 | Completed

• 1 other identifier: FIN-BEM-2016-04
• Study Type: observational
• Target: 1,195
• Locations: 1 country
• Sites: 1

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

Conditions

Infertility

Keywords

Bemfola; r-hFSH; Oocytes; Pregnancy; OHSS

Outcome Measures

Primary Outcomes (1)

• Number of oocytes retrieved

  34-36 hours after hCG administration

Secondary Outcomes (14)

• 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

Interventions

r-hFSH DRUG

As per standard clinical practice

Also known as: Bemfola

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Finox AG: lead

Study Sites (1)

Team Kinderwunsch Oldenburg

Oldenburg, Lower Saxony, 26121, Germany

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Jan-Steffen Krüssel, MD

  Leiter universitäres interdisziplinäres Kinderwunschzentrum Düsseldorf (UniKiD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: October 24, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

DE (1)