A multi-centre phase 3 study comparing efficacy and safety of Bemfola(®) versus Gonal-f(®) in women undergoing ovarian stimulation for IVF

Reproductive Biomedicine Online
Manfred RettenbacherB Imthurn

Abstract

Bemfola (follitropin alfa) (Finox AG, Switzerland), a new recombinant FSH, has a comparable pharmacological profile to that of Gonal-f (Merck Serono, Germany), the current standard for ovarian stimulation. A randomized, multi-centre, Phase 3 study in women undergoing IVF or intracytoplasmic sperm injection (n = 372) showed Bemfola yielding similar efficacy and safety profiles to Gonal-f. Women aged 20-38 years of age were randomized 2:1 to receive a single, daily, subcutaneous 150 IU dose of either Bemfola or Gonal-f. This study tested equivalence in the number of retrieved oocytes using a pre-determined clinical equivalence margin of ±2.9 oocytes. Compared with Gonal-f, Bemfola treatment resulted in a statistically equivalent number of retrieved oocytes (Bemfola 10.8 ± 5.11 versus Gonal-f 10.6 ± 6.06, mean difference: 0.27 oocytes, 95% confidence interval: -1.34, 1.32) as well as a similar clinical pregnancy rate per embryo transfer in first and second cycles (Bemfola: 40.2% and 38.5%, respectively; Gonal-f: 48.2% and 27.8%, respectively). No difference in severe ovarian hyperstimulation syndrome was observed between treatment groups (Bemfola: 0.8%; Gonal-f: 0.8%). This study demonstrates similar clinical efficacy and safety p...Continue Reading

Associated Clinical Trials

Jul 21, 2015·Antonio Requena

References

Dec 23, 2003·Human Reproduction·UNKNOWN Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group
Sep 25, 2004·Critical Care Clinics·Jaime F AvecillasAlejandro C Arroliga
Sep 25, 2004·Human Reproduction Update·Bruno Lunenfeld
Feb 5, 2009·Reproductive Biomedicine Online·F OlivennesUNKNOWN CONSORT study group
Oct 16, 2009·The New England Journal of Medicine·Alfred B EngelbergJerry Avorn
Jan 12, 2010·Nature Biotechnology·Huub Schellekens, Ellen Moors
Apr 1, 2010·BJOG : an International Journal of Obstetrics and Gynaecology·K JayaprakasanN Raine-Fenning
Sep 21, 2010·Gynecological Endocrinology : the Official Journal of the International Society of Gynecological Endocrinology·Klaus Bühler, Olaf Naether
Jan 13, 2012·Human Reproduction·Scott M NelsonAntonio La Marca
Jun 15, 2012·The Cochrane Database of Systematic Reviews·Annefloor W PouwerJan A M Kremer
Oct 25, 2012·Blood·Martina WeiseChristian K Schneider
Oct 1, 2013·Human Reproduction Update·Antonio La Marca, Sesh Kamal Sunkara

❮ Previous
Next ❯

Citations

Dec 15, 2015·Journal of Obstetrics and Gynaecology of India·Gautam N Allahbadia
Jul 22, 2015·Reproductive Biomedicine Online·Hermann M BehreUNKNOWN PERSIST Study Investigators
Jun 16, 2016·Reproductive Biology and Endocrinology : RB&E·Raoul Orvieto, David B Seifer
Sep 28, 2016·Reproductive Biology and Endocrinology : RB&E·Thomas StrowitzkiPeter Bias
May 28, 2017·Human Fertility : Journal of the British Fertility Society·Graham FoxonJulian Jenkins
Jul 25, 2019·Frontiers in Endocrinology·Bruno LunenfeldSesh K Sunkara
Aug 4, 2020·Fertility Research and Practice·Marcos FerrandoUNKNOWN BIRTH study group
Jul 14, 2020·Gynecological Endocrinology : the Official Journal of the International Society of Gynecological Endocrinology·Maria Cristina BudaniGian Mario Tiboni
Jun 3, 2017·Journal of Assisted Reproduction and Genetics·Mindy S ChristiansonZeev Shoham
May 20, 2020·Journal of Clinical Medicine·Maurizio De Rocco PonceAndrea Garolla
Aug 10, 2019·Frontiers in Endocrinology·Laura RiccettiLivio Casarini
Dec 18, 2020·Expert Opinion on Drug Delivery·Helen SaundersHelen Kendrew
Dec 24, 2020·European Journal of Hospital Pharmacy. Science and Practice·Svetoslav StoevBoyka Petkova
Aug 11, 2019·European Journal of Obstetrics, Gynecology, and Reproductive Biology·Zarema BarakhoevaMikhail Polzikov
Apr 1, 2021·Expert Review of Pharmacoeconomics & Outcomes Research·Marina Šprem GoldštajnAntonio Simone Laganà
Sep 4, 2021·Reproductive Biomedicine Online·Lien Van den HauteChristophe Blockeel

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.