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

A Dose-response Trial Using FE 999049 in Japanese Women Undergoing in Vitro Fertilisation (IVF) / Intracytoplasmic Sperm Injection (ICSI) Treatment

Phase 2
Completed
Conditions
Interventions
First Posted Date
2014-12-05
Last Posted Date
2020-12-14
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
159
Registration Number
NCT02309671
Locations
🇯🇵

Investigational site (there may be other sites in this country), Tokyo, Japan

Comparison Between Laparoscopic Ovarian Diathermy and Urinary Purified FSH in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome.

First Posted Date
2014-12-02
Last Posted Date
2017-01-23
Lead Sponsor
Cairo University
Target Recruit Count
210
Registration Number
NCT02304536
Locations
🇪🇬

BeniSuef University hospitals, BeniSuef, Egypt

🇪🇬

Cairo University Hospitals, Cairo, Egypt

Comparison Between Letrozole and Urinary Purified FSH in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome.

Phase 3
Completed
Conditions
Interventions
First Posted Date
2014-12-01
Last Posted Date
2016-07-06
Lead Sponsor
Cairo University
Target Recruit Count
140
Registration Number
NCT02304107
Locations
🇪🇬

BeniSuef University hospitals, BeniSuef, Egypt

🇪🇬

Cairo University Hospitals, Cairo, Egypt

Human Growth Hormone Pre-treatment for 6 Weeks Prior to Ovulation Induction for IVF

First Posted Date
2014-07-01
Last Posted Date
2020-02-18
Lead Sponsor
Center for Human Reproduction
Target Recruit Count
30
Registration Number
NCT02179255
Locations
🇺🇸

Center for Human Reproduction, New York, New York, United States

Efficacy of Recombinant FSH/GnRH Antagonist Protocol With and Without LH Adjunct for Egg Bank Donation

First Posted Date
2014-02-24
Last Posted Date
2018-03-23
Lead Sponsor
Michigan Reproductive Medicine
Target Recruit Count
38
Registration Number
NCT02069808
Locations
🇺🇸

Michigan Reproductive Medicine, Bloomfield Hills, Michigan, United States

FSH in GnRH-AntagoniST Controlled Ovarian Hyperstimulation Cycles (FAST)

Phase 4
Completed
Conditions
Interventions
First Posted Date
2013-10-25
Last Posted Date
2019-10-09
Lead Sponsor
IBSA Institut Biochimique SA
Target Recruit Count
710
Registration Number
NCT01969201
Locations
🇨🇭

Universitätsklinik für Frauenheilkunde, Bern, Be, Switzerland

🇮🇹

IRCCS San Raffaele, Milan, Italy

🇧🇪

Universitair Ziekenhuis Brussel, Brussels, Belgium

and more 13 locations

Efficacy and Safety of FSH-GEX™ in Comparison With 150 IU Gonal-f®

Phase 2
Completed
Conditions
Interventions
First Posted Date
2013-02-18
Last Posted Date
2021-05-07
Lead Sponsor
Glycotope GmbH
Target Recruit Count
267
Registration Number
NCT01794208
Locations
🇭🇺

Glycotope Investigational Site, Tapolca, Hungary

🇩🇪

Glycotope Investigational Medical Director, Bielefeld, Germany

Anti-Mullerian Hormone (AMH) Versus Antral Follicle Count (AFC) Guided rFSH Dosing Study

Phase 4
Completed
Conditions
Interventions
First Posted Date
2013-02-04
Last Posted Date
2013-02-04
Lead Sponsor
Vietnam National University
Target Recruit Count
348
Registration Number
NCT01783301
Locations
🇻🇳

Research Center for Genetics and Reproductive Health, Ho Chi Minh, Vietnam

Predicting Ovarian Response in Artificial Insemination With Low Stimulation

First Posted Date
2012-08-10
Last Posted Date
2012-12-13
Lead Sponsor
Isala
Target Recruit Count
510
Registration Number
NCT01662180
Locations
🇳🇱

UMC Utrecht, Utrecht, PO box 85500, Netherlands

🇳🇱

Catharina Ziekenhuis, Eindhoven, PO box 1350, Netherlands

🇳🇱

st Elizabeth Gasthuis, Tilburg, PO box 90151, Netherlands

and more 4 locations

Trial to Assess the Clinical Efficacy and Safety of MSJ-0011 in Inducing Ovulation in Anovulatory or Oligo-ovulatory Japanese Women

First Posted Date
2012-07-31
Last Posted Date
2016-01-07
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Target Recruit Count
81
Registration Number
NCT01653743
Locations
🇯🇵

Bashamichi Ladies Clinic, Kanagawa, Japan

🇯🇵

Hanabusa Women's Central Fertility Clinic, Hyogo, Japan

🇯🇵

Sophia Ladies Clinic, Kanagawa, Japan

and more 3 locations
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