news

Ferring announces data from its Phase III ESTHER trials

0
SHARES

Posted: 4 July 2016 | | No comments yet

ESTHER-1 assessed an individualised dosing regimen of follitropin delta compared to follitropin alfa in women undergoing their first cycle of IVF…

Ferring Pharmaceuticals have announced data from their ESTHER trials at the Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE).

 

ACCESS your FREE COPY

 


This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.

Access the full report now to discover the techniques, tools and innovations that are transforming pharmaceutical formulation, and learn how to position your organisation for long-term success.

What you’ll discover:

  • Key trends shaping the pharmaceutical formulation sector
  • Innovations leading progress in pharmaceutical formulation and how senior professionals can harness their benefits
  • Considerations and best practices when utilising QbD during formulation of oral solid dosage forms
  • And more!

Don’t miss your chance to access this exclusive report ! Access now – it’s free

follitropin delta

ESTHER-1, a randomised, assessor-blind, controlled, multicentre Phase III trial in women aged 18–40 years undergoing their first cycle of in-vitro fertilisation (IVF) or intracytoplasmic injection (ICSI), assessed an individualised dosing regimen of follitropin delta compared to follitropin alfa (conventional dosing regimen).

The individualised dosing regimen for follitropin delta was based on the patient’s serum anti-Müllerian hormone (AMH) level (a parameter used to assess ovarian reserve) and body weight. This individualised dosing regimen was used from the first day of controlled ovarian stimulation to determine an appropriate dose of FSH with the aim of minimising the risk of poor and excessive ovarian response in IVF or ICSI.

Non-inferiority was demonstrated for the co-primary endpoints of ongoing pregnancy rate (30.7% vs 31.6%) and ongoing implantation rate (35.2% vs 35.8%) for follitropin delta compared to follitropin alfa.

Translating personalised medicine into reproductive health

Secondary endpoints, including the number of oocytes retrieved and number of blastocysts obtained, were comparable between both groups. In addition, ovarian hyperstimulation syndrome (OHSS) and/or OHSS preventive interventions occurred less frequently in women receiving follitropin delta than in women in the follitropin alfa group.

“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,” commented Joan-Carles Arce, M.D., Ph.D., Vice President Clinical Research & Development, Ferring. “We believe that by focusing on innovative and personalised approaches to treatment, we can continue to lead the way in assisted reproductive technology.”

Additional data from the ESTHER-2 trial presented at the meeting demonstrated no increased immunogenicity risk following controlled ovarian stimulation with follitropin delta after exposure in repeated cycles.

Related topics

Related organisations

Share via
Share via