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

Impact of Blastocyst Morphological Development and Blastocoele Re-expansion on Pregnancy Outcome After Using REKOVELLE®

First Posted Date
2018-10-05
Last Posted Date
2023-12-12
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
362
Registration Number
NCT03697031
Locations
🇩🇰

Ciconia, VivaNeo (there may be other sites in this country), Højbjerg, Denmark

Study to Assess the Patterns of Use of REKOVELLE® in Naïve Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures

First Posted Date
2018-01-09
Last Posted Date
2023-02-09
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
1018
Registration Number
NCT03393780
Locations
🇮🇹

Policlinico di Milano (there may be other sites in this country), Milan, Italy

🇵🇱

Invicta Fertility Clinic Gdansk (there may be other sites in this country), Gdańsk, Poland

🇳🇱

Erasmus Medisch Centrum (there may be other sites in this country), Rotterdam, Netherlands

and more 7 locations

Step Down FSH Approach and Late Follicular Phase in Progesterone Level

Early Phase 1
Completed
Conditions
Interventions
First Posted Date
2017-11-29
Last Posted Date
2020-09-09
Lead Sponsor
ART Fertility Clinics LLC
Target Recruit Count
127
Registration Number
NCT03356964
Locations
🇦🇪

IVI Middle East Fertilty Clinic, Abu Dhabi, United Arab Emirates

Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Pan-Asian Women

First Posted Date
2017-09-28
Last Posted Date
2023-08-24
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
1011
Registration Number
NCT03296527
Locations
🇨🇳

Beijing Obstetrics and Gynecology Hospital,Capital Medical University, Beijing, China

🇨🇳

ShengJing Hospital of China Medical University, Shenyang, China

🇨🇳

The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China

and more 23 locations

Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women

Phase 3
Completed
Conditions
Interventions
First Posted Date
2017-07-25
Last Posted Date
2023-08-24
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
373
Registration Number
NCT03228680
Locations
🇯🇵

Investigational Site 8121, Chiba-shi, Chiba, Japan

🇯🇵

Yachiyo Hospital, Anjo, Aichi, Japan

🇯🇵

Saint Women's Clinic, Saitama, Japan

and more 14 locations

Gonapure® in Multifollicular Stimulation in Egyptian Women Undergoing IVF/ICSI

Phase 4
Conditions
Interventions
First Posted Date
2017-02-20
Last Posted Date
2017-08-30
Lead Sponsor
MinaPharm Pharmaceuticals
Target Recruit Count
200
Registration Number
NCT03057574
Locations
🇪🇬

Alexandria University, Alexandria, Egypt

🇪🇬

Ain Shams University, Cairo, Egypt

Effectiveness and Safety Study of Fixed Versus Flexible of Gonadotropin-releasing Hormone Antagonist Protocol

First Posted Date
2015-12-21
Last Posted Date
2015-12-21
Lead Sponsor
Chong Qing Reproducive and Genetic Institute
Target Recruit Count
200
Registration Number
NCT02635607

Efficacy of Corifollitropin Alfa Versus Follitropin Beta in Aged IVF (In-vitro Fertilization) Patients

First Posted Date
2015-06-09
Last Posted Date
2017-08-22
Lead Sponsor
Vietnam National University
Target Recruit Count
400
Registration Number
NCT02466204
Locations
🇻🇳

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

🇻🇳

My Duc Hospital, Ho Chi Minh City, Vietnam

FSH Receptor Polymorphism p.N680S and Efficacy of FSH Therapy

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-01-29
Last Posted Date
2016-07-12
Lead Sponsor
Azienda USL Modena
Target Recruit Count
88
Registration Number
NCT02349945
Locations
🇩🇪

Zentrums für Reproduktions-medizin und Andrologie Universitätsklinikum Halle (Saale), Martin-Luther-Universität Halle-Wittenberg, Halle, Germany

🇮🇹

AziendaUSLModena, Modena, Italy

🇮🇹

Department of Medical Pathophysiology, University of Rome La Sapienza, Lab of Seminology & Immunology of Reproduction, Rome, Italy

and more 3 locations
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