Follitropin

Generic Name
Follitropin
Brand Names
Bemfola, Follistim, Gonal F, Gonal-F, Menopur, Ovaleap, Pergoveris, Puregon, GONAL-f, Rekovelle
Drug Type
Biotech
Chemical Formula
-
CAS Number
146479-72-3
Unique Ingredient Identifier
2M2GGL7HUP
Background

Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.

Indication

In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).

Associated Conditions
-
Associated Therapies
Assisted Reproductive Technology therapy, Controlled Ovarian Stimulation

Efficacy and Tolerability of Human FSH Versus Recombinant FSH (Follitropin Alpha) in ICSI.

Phase 3
Completed
Conditions
Interventions
First Posted Date
2006-06-12
Last Posted Date
2015-03-27
Lead Sponsor
IBSA Institut Biochimique SA
Target Recruit Count
151
Registration Number
NCT00335725
Locations
🇭🇺

Semmelweis Medical School, Budapest, Hungary

🇫🇷

Hôpital Edouard Herriot, Lyon, France

🇫🇷

Institut de Médecine de la Reproduction, Marseille, France

and more 4 locations

A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa

Phase 4
Completed
Conditions
Interventions
First Posted Date
2005-11-23
Last Posted Date
2010-02-26
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
80
Registration Number
NCT00257556
Locations
🇬🇧

The Royal Hallamshire Hospital, University of Sheffield, Jessop Wing, Tree Root Walk, Sheffield, United Kingdom

🇬🇧

Leeds General Infirmary, Great George Street, Leeds, United Kingdom

🇩🇪

Gemeinschaftspraxis und Tagesklinik, Zingel 29, Hildesheim, Germany

and more 3 locations

Luteal Phase FSH in the IVF Poor Responder

Phase 4
Completed
Conditions
Interventions
First Posted Date
2005-09-23
Last Posted Date
2015-12-03
Lead Sponsor
University of Pennsylvania
Target Recruit Count
20
Registration Number
NCT00225433
Locations
🇺🇸

University of Pennsylvania Reproductive Research Unit, Philadelphia, Pennsylvania, United States

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