Swiss-based biopharmaceutical company Ferring Pharmaceuticals has reported a Phase III, evidence-based stimulation trial with a human recombinant follicle-stimulating hormone (FSH) in Europe and Rest of World (ESTHER) trials of follitropin delta for pregnancy-related complexities.
Follitropin delta is a recombinant FSH derived from a human cell line (human rFSH).
ESTHER-1 is a randomised, assessor-blind, controlled, multicentre trial, which involved women aged between 18 to 40 undergoing their first cycle of in-vitro fertilisation (IVF) or intracytoplasmic injection (ICSI).
Ferring clinical research and development vice-president Joan-Carles Arce said: "This trial is an integral part of Ferring’s commitment to help couples conceive by translating the practice of personalised medicine into reproductive health and fertility.
"We believe that by focusing on innovative and personalised approaches to treatment, we can continue to lead the way in assisted reproductive technology."
Patients were administered with an individualised dosing regimen of follitropin delta compared to follitropin alfa (conventional dosing regimen).
The individualised dosing regimen for follitropin delta was determined on the basis of the patient’s serum anti-Müllerian hormone (AMH) level and body weight.
This regimen was applied from the first day of controlled ovarian stimulation to determine an appropriate dose of FSH while ensuring minimum risk of poor and excessive ovarian response in IVF or ICSI.
Non-inferiority was exhibited as a part of the co-primary endpoints of ongoing pregnancy rate and ongoing implantation rate for follitropin delta compared to follitropin alfa.
As for secondary endpoints, number of oocytes retrieved and number of blastocysts obtained, were comparable between both groups.
Additionally it displayed a less frequent occurrence of ovarian hyperstimulation syndrome (OHSS) and / or OHSS preventive interventions.
Data from the ESTHER-2 trial, under which a subset of women underwent additional assessor-blind stimulation cycles, showed no increased immunogenicity risk following controlled ovarian stimulation with follitropin delta after exposure in repeated cycles.