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Follitropin

Generic Name
Follitropin
Brand Names
Bemfola, Follistim, Gonal F, Gonal-F, Menopur, Ovaleap, Pergoveris, Puregon, GONAL-f, Rekovelle
Drug Type
Biotech
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 Therapies
Assisted Reproductive Technology therapy, Controlled Ovarian Stimulation

Study on the Pharmacokinetics and Safety of QL1012D and Gonal-F® in Healthy Female Volunteers

Phase 1
Not yet recruiting
Conditions
Infertility, Female
Interventions
Drug: Gonal-F®
First Posted Date
2025-03-07
Last Posted Date
2025-03-11
Lead Sponsor
Qilu Pharmaceutical Co., Ltd.
Target Recruit Count
48
Registration Number
NCT06864793

Effects of LH and FSH on Metabolic Regulation in Cumulus Cells

Not Applicable
Recruiting
Conditions
Unrecognized Condition
Interventions
Drug: FSH and LH
First Posted Date
2025-01-31
Last Posted Date
2025-01-31
Lead Sponsor
Kaohsiung Veterans General Hospital.
Target Recruit Count
60
Registration Number
NCT06803199
Locations
🇨🇳

Kaohsiung Veterans General Hospital, Kaohsiung City, Taiwan

Bioequivalence Clinical Trial of Recombinant Human Follicle-stimulating Hormone JZB30

Phase 1
Completed
Conditions
Bioequivalence
Healthy Volunteers
Pharmacokinetics
Safety
Immunogenicity
Interventions
First Posted Date
2025-01-16
Last Posted Date
2025-01-16
Lead Sponsor
West China Second University Hospital
Target Recruit Count
48
Registration Number
NCT06778304
Locations
🇨🇳

West China Second University Hospital, Chengdu, Sichuan, China

An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta at Different Time Intervals During Controlled Ovarian Stimulation.

Phase 1
Recruiting
Conditions
Infertility
Interventions
First Posted Date
2024-07-22
Last Posted Date
2025-01-24
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
200
Registration Number
NCT06511791
Locations
🇪🇸

Ferring Investigational Site, Valencia, Spain

Possible Action of Resveratrol in Improving the Outcomes of IVF/ICSI in Couples With Unexplained Infertility

Not Applicable
Recruiting
Conditions
Unexplained Infertility
Interventions
Dietary Supplement: Resveratrol-based multivitamin supplement
Dietary Supplement: Folic acid
Procedure: IVF/ICSI
First Posted Date
2024-07-01
Last Posted Date
2024-07-01
Lead Sponsor
Andros Day Surgery Clinic
Target Recruit Count
90
Registration Number
NCT06481696
Locations
🇮🇹

ANDROS Day Surgery Clinic, Palermo, Italy

An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta During Controlled Ovarian Stimulation

Phase 1
Recruiting
Conditions
Fertility
Interventions
First Posted Date
2024-06-20
Last Posted Date
2025-03-12
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
600
Registration Number
NCT06466486
Locations
🇪🇸

Ferring Investigational Site, Valencia, Spain

Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome

Phase 1
Recruiting
Conditions
Infertility
Obesity
Interventions
First Posted Date
2024-05-16
Last Posted Date
2024-11-27
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
5
Registration Number
NCT06414096
Locations
🇺🇸

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study

Phase 4
Not yet recruiting
Conditions
Ovarian Stimulation
Quality of Life
Preimplantation Genetic Testing
Fertility Preservation
Interventions
Drug: Gonapeptyl®
Drug: Cerazette®
First Posted Date
2023-12-19
Last Posted Date
2025-01-15
Lead Sponsor
University Hospital, Ghent
Target Recruit Count
60
Registration Number
NCT06175832

A Randomised Trial Comparing the Ovarian Response of a Starting Dose of Either 10 Μg or 15 Μg Follitropin Delta (FE 999049) to a Starting Dose of Either 150 IU or 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in China

Phase 3
Active, not recruiting
Conditions
Infertility, Female
Interventions
First Posted Date
2023-12-18
Last Posted Date
2025-03-03
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
300
Registration Number
NCT06173869
Locations
🇨🇳

Ferring Investigational Site, Tianjin, Tianjin, China

Retrospective Study of High Dose Follitropin Delta in a Mixed Protocol With Human Chorionic Gonadotropin

Active, not recruiting
Conditions
Infertility
IVF
Interventions
First Posted Date
2023-05-24
Last Posted Date
2023-10-31
Lead Sponsor
Clinique Ovo
Target Recruit Count
150
Registration Number
NCT05873725
Locations
🇨🇦

Clinique Ovo, Montreal, Quebec, Canada

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