A randomised, controlled, assessor-blind, parallel groups, multicentre trial in India comparing the efficacy and safety of FE 999049 (follitropin delta) with follitropin alfa (GONAL-F) in controlled ovarian stimulation in women undergoing an assisted reproductive technology programme

开始日期2021-05-01

申办/合作机构

Ferring Pharmaceuticals A/S

[+1]

NCT04854707

/ CompletedN/A

An Observational Study "FOLLITROPIN" Comparing the Efficacy of Follitropin Alpha Biosimilar: the Real-world Data

Aim to investigate the efficacy of follitropin alpha biosimilar therapy (Primapur®) in nonselected real-world population.

开始日期2020-01-12

申办/合作机构

IVFarma LLC

[+1]

NCT03088137

/ Completed临床3期

Multicentre Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment

The purpose of this study is to show equivalence with regard to the number of oocytes retrieved between follitropin alfa (pen-injectors) Primapur® and Gonal-f® in woman undergoing IVF/ICSI

开始日期2017-02-08

申办/合作机构

IVFarma LLC

[+2]

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项与促卵泡激素α生物类似药(Bridge Pharmaceuticals, Inc.) 相关的文献（医药）

2026-02-01·CLINICAL PHARMACOLOGY & THERAPEUTICS

Real‐World Effectiveness and Safety of Recombinant Human Follicle‐Stimulating Hormone (rhFSH) in Infertile Women undergoing Assisted Reproductive Technology (ART): A Korean Nationwide Cohort Study

Article

作者: Ju-Young Shin ; Ji Hyang Kim ; Hoon Kim ; Hee-Jin Seo ; Jung Ryeol Lee ; Joong Yeup Lee ; Chang-Woo Choo ; Yunju Choe ; Hyesung Lee ; Yujeong Shin ; Eun-Young Choi ; Yejin Jeon ; Young Sik Choi

Despite widespread rhFSH use in infertile women undergoing ART, real‐world comparative data on its effectiveness and safety across different rhFSH types remain limited. Using the HIRA claims database, we included 10,684 women aged 20–39 with infertility (2016–2021) who used only rhFSH in their first in vitro fertilization–embryo transfer (IVF‐ET). Outcome variables comprised effectiveness (≥ 11 oocytes retrieved, pregnancy rates and live birth rate) and safety (ectopic pregnancy, miscarriage, preterm birth and ovarian hyperstimulation syndrome [OHSS]) in the whole cohort, further categorized into follitropin and other rhFSH. Baseline characteristics were described, and relative risks (RR) with 95% confidence intervals (CI) were estimated using a generalized linear model, adjusting for age and imbalanced variables. Of 10,684 patients prescribed rhFSH, 7.1% were aged 20–29, 41.6% were 30–34, and 51.3% were 35–39. ICSI was utilized in 57.7% of cycles, and 76.8% used the GnRH antagonist protocol. The live birth rate was 38.8%, and the OHSS rate was 5.9%. Comparing baseline characteristics of the follitropin ( n = 2,594) and other rhFSH group ( n = 8,090), ICSI (62.2% vs. 56.3%) and GnRH antagonist protocol (81.3% vs. 75.3%) were more common in the follitropin group. Women who received follitropin were more likely to have ≥ 11 oocytes retrieved (adjusted RR, 1.09; 95% CI: 1.02–1.16) and less likely to have OHSS (adjusted RR, 0.73; 95% CI: 0.60–0.90). These findings provide real‐world evidence supporting rhFSH effectiveness and safety in fresh IVF cycles, with follitropin potentially offering advantages in oocyte retrieval and reduced OHSS rates.

2024-12-01·ARCHIVES OF MEDICAL RESEARCH

Follicle-Stimulating Hormone Sweetness: How Carbohydrate Structures Impact on the Biological Function of the Hormone

Review

作者: Dias, James A ; Dias, James A. ; Ulloa-Aguirre, Alfredo ; Llamosas, Regina

Follicle-stimulating hormone (FSH), or follitropin, exists in multiple molecular forms due largely to its protein-carbohydrate composition and the complexity of the glycans attached to the protein core. The heterogeneity of gonadotropins exists in two forms, macroheterogeneity, which results from the absence of one or two oligosaccharide chains in the ß-subunit, and microheterogeneity which results from variation in the structures and complexity of the glycans attached to the hormone. In the clinical arena, FSH compounds are widely used by fertility specialists to promote ovarian follicle growth and maturation to a preovulatory follicle containing a fertilization-competent oocyte. Several genetically engineered recombinant human FSH preparations have been added to the arsenal of follitropin preparations in several countries for the treatment of infertility, particularly in women attending assisted reproduction clinics. Although the primary structure of these recombinant proteins is identical to that of naturally occurring FSH, the cell context and variations in the production and purification processes may impact the glycosidic profile of the recombinant FSH macro- and micro-heterogeneity, which may potentially influence the pharmacokinetics and pharmacodynamics of the compound. This review concentrates on the structure-function correlates of follitropin, with emphasis on the physiological and biological importance of the carbohydrates attached to its protein core, including its pharmacokinetics and biological activity. Emphasis is placed on pituitary FSH, and the available data on the various recombinant FSH preparations employed in therapeutics are also discussed, considering that this gonadotropin represents the cornerstone for the treatment of infertility in modern assisted reproduction.

2024-09-01·FERTILITY AND STERILITY

Individualized dosing of follitropin delta affects live birth and safety in in vitro fertilization treatment: an individual participant data meta-analysis of randomized controlled trials

Review

作者: Martin Shaw ; Scott M. Nelson ; Richard A. Anderson ; Karema Alrashid

OBJECTIVE:

To undertake a one-stage meta-analysis of individual patient data from randomized trials comparing individualized dosing of follitropin delta vs. other forms of follitropin (alpha and beta) for live birth (LB) rates (LBR) and safety parameters in women undergoing ovarian stimulation for in vitro fertilization treatment.

DESIGN:

Systematic review with individual patient data meta-analysis.

SETTING:

Not applicable.

PATIENTS:

Women undergoing ovarian stimulation for in vitro fertilization treatment.

INTERVENTIONS:

We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and the Web of Science to identify eligible phase 3 trials between January 1, 2000, and February 1, 2023.

MAIN OUTCOME MEASURES:

All analyses were based on individual participant data. We used a general linear mixed effects logistic regression model using fixed effects for treatment drugs interacting with log (AMH) level, age, and random effects for country and trial to compare the primary efficacy and safety outcomes of LB and early ovarian hyperstimulation syndrome (OHSS) and/or the need for OHSS preventative measures, with ovarian stimulation parameters and neonatal outcomes also assessed. PROSPERO registration: CRD42023399711.

RESULTS:

Three trials met inclusion criteria and included 2,685 women undertaking 2,682 cycles between October 2013 and May 2020, with LB follow-up through to February 1, 2023. For women with an elevated AMH level (≥15 pmol/L), there was high-quality evidence that the use of individualized dosing of follitropin delta was associated with an increased LB rate (adjusted odds ratio [adj OR] 1.64, 95% confidence interval [CI] 1.14, 2.36). Safety outcomes were also improved with a reduced risk of both early OHSS and/or the need for preventative interventions (adj OR 0.27, 95% CI 0.15, 0.49) and early moderate or severe OHSS (adj OR 0.30, 95% CI 0.16, 0.58). These improvements in outcomes were obtained with a lower total dose of gonadotropin (-48.7 μg, 95% CI -53.7, -43.8) and no adjustments in the daily dose. In contrast, similar LB rates (adj OR 0.86, 95% CI 0.63, 1.17) and safety outcomes (adj OR 1.92, 95% CI 0.76, 4.87) were observed for women with an AMH level of <15 pmol/L. There were no clinically meaningful differences in neonatal outcomes.

CONCLUSION:

Using follitropin delta in an AMH level and weight-based algorithm rather than conventional licensed dosing of follitropin alpha or beta for ovarian stimulation in women is associated with improved LB rates and safety outcomes for women with elevated AMH levels.

项与促卵泡激素α生物类似药(Bridge Pharmaceuticals, Inc.) 相关的新闻（医药）

2025-07-02

·PipelineReview

Ferring ADAPT-1 Trial Builds on Dosing Evidence for Follitropin Delta

PARIS, France I July 02, 2025 I Follitropin delta starting dose of 15 micrograms (µg)/day has comparable efficacy and safety as a starting dose of 225 International Units (IU)/day of follitropin alfa for ovarian stimulation in vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI) gonadotrophin-releasing hormone (GnRH) antagonist protocol cycles. This is the key finding of a trial presented today at the European Society of Human Reproduction and Embryology (ESHRE) Congress in Paris and published in Human Reproduction . These data build on previous studies which have established an estimated point of clinical correspondence for 10 µg follitropin delta to 150 IU follitropin alfa in this class of medications. 1,2 The ADAPT-1 trial was a multicentre, randomised, assessor-blind study involving 300 women aged 18-40 years undergoing IVF or ICSI. 3 The trial compared the efficacy and safety of follitropin delta and follitropin alfa using conventional dosing regimens with a primary endpoint of number of oocytes retrieved. Currently, follitropin delta is approved for use via a dosing algorithm based on serum anti-Müllerian Hormone (AMH) and bodyweight individualised for each patient, and aims to obtain an ovarian response which is associated with a favourable safety/efficacy profile. The clinical value of this approach has been well established 4,5,6,7,8 , particularly in treatment-naïve patients where the algorithm aims to achieve 8–14 retrieved oocytes while minimising the risk of ovarian hyperstimulation syndrome (OHSS) to optimise the live birth rate in a fresh and frozen transfer cycle. 4,5,6,7,8 Key Findings: Dr Andrea Bernabeu, Medical Director at Instituto Bernabeu and principal investigator of the ADAPT-1 trial, said: “No patients we see as fertility doctors are the same and the ability to optimise therapy based on patients age, treatment goal and whether they have a high or low response to follicular stimulation are all relevant. These data provide confidence and expand our understanding for dosing in follitropin delta.” Pierre-Yves Berclaz, Chief Science and Medical Officer at Ferring Pharmaceuticals, stated: “The ADAPT-1 trial results confirm the efficacy and safety of follitropin delta across the full range of dosing strategies, making it the only recombinant FSH with robust clinical evidence supporting multiple dosing strategies. Ferring will take forward the implications of this study in future dialogue with regulatory authorities.” About GnRH protocols Gonadotrophin-releasing hormone (GnRH) agonists and antagonists are used as concomitant treatment during ovarian stimulation to prevent premature luteinisation and ovulation for IVF/ICSI. 7,8 About Follitropin Delta (Rekovelle ® ) Follitropin delta is a human cell line-derived rFSH with an approved dosing algorithm designed for a predictable ovarian response. 3 It is the first rFSH derived from a human cell line (PER.C6 ® cell line). Follitropin delta is structurally and biochemically distinct from other existing rFSH gonadotrophins. 3,4 Follitropin delta is approved in certain markets for use in controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART), such as IVF or ICSI cycle. The individualised dosing of follitropin delta is determined using an approved algorithm, based on a woman’s AMH level and body weight. 3,5 AMH is a biomarker used to assess ovarian reserve and can help predict ovarian response. 5,6 The follitropin delta dose should be based on AMH level, measured using the ELECSYS AMH Plus immunoassay from Roche, the ACCESS AMH Advanced from Beckman Coulter, or LUMIPULSE G AMH from Fujirebio. 3 About Ferring Pharmaceuticals Ferring Pharmaceuticals is a privately owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine with a strong heritage in areas of gastroenterology and urology, and are at the forefront of innovation in uro-oncology gene therapy. Ferring was founded in 1950 and employs more than 7,000 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which market its medicines in over 100 countries. Learn more at www.ferring.com , or connect with us on LinkedIn , Instagram , YouTube , Facebook and X . REFERENCES 1 – Arce JC, Larsson P, Garcia-Velasco JA; Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa; RBMO; 2020 2 – Yang R, Zhang Y, Liang X et al; Comparative clinical outcome following individualized follitropin delta dosing in Chinese women undergoing ovarian stimulation for in vitro fertilization / intracytoplasmic sperm injection; Reproductive Biology and Endocrinology; 2022 3 – Clinical Trials.gov page: https://clinicaltrials.gov/study/NCT05263388 (Accessed June 2025) 4 – Andersen, A. N., Nelson, S. M., Fauser, B. et al. (2017). Individualized versus conventional ovarian stimulation for in vitro fertilization: A multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. Fertility and Sterility, 107(2), 387-396. 5 – Bosch E, Havelock J, Martin FS, Rasmussen BB, Klein BM, Mannaerts B, Arce JC; ESTHER-2 Study Group. Follitropin delta in repeated ovarian stimulation for IVF: a controlled, assessor-blind Phase 3 safety trial. Reprod Biomed Online. 2019 Feb;38(2):195-205. PMID: 30594482. 6 – Ishihara O, Arce JC, Japanese Follitropin Delta Phase 3 Trial G. Individualized follitropin delta dosing reduces OHSS risk in Japanese IVF/ICSI patients: a randomized controlled trial. Reprod Biomed Online. 2021 May;42(5):909-18. PubMed PMID: 33722477. Epub 2021/03/17. 7 – Qiao J, Zhang Y, Liang X, et al. A randomised controlled trial to clinically validate follitropin delta in its individualised dosing regimen for ovarian stimulation in Asian IVF/ICSI patients. Hum Reprod. 2021 Jun 28;36(9):2452-62. PubMed PMID: 34179971. Epub 2021/06/29. 8 – Blockeel C, Griesinger G, Rago R, et al. Prospective multicenter non-interventional real-world study to assess the patterns of use, effectiveness and safety of follitropin delta in routine clinical practice (the PROFILE study). Frontiers in Endocrinology. 2022 Dec 22;13:992677. PMID: 36619578. SOURCE: Ferring Pharmaceuticals

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适应症	最高研发状态	国家/地区	公司	日期
女性不孕症	临床3期	-	Bridge Pharmaceuticals, Inc.	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03088137 (RCT 754, Pubmed \| Eur J Obstet Gynecol Reprod Biol) 人工标引	临床3期	不孕	110	follitropin alpha (follitropin alpha biosimilar)	築構築顧醖衊鹹窪構積(選醖夢窪淵築衊壓壓艱) = 窪醖醖鏇網夢鑰獵襯夢繭膚觸簾齋網憲鏇觸製 (艱淵積憲鏇獵壓獵觸艱, 7.28) 更多	相似	2019-10-01
				follitropin alpha (original follitropin alpha)	築構築顧醖衊鹹窪構積(選醖夢窪淵築衊壓壓艱) = 網網蓋鹽襯膚夢鑰積鬱繭膚觸簾齋網憲鏇觸製 (艱淵積憲鏇獵壓獵觸艱, 6.29) 更多
NCT03857230 (CTgov)	临床1期	-	28	Primapur (Primapur)	壓蓋淵夢鏇選鹽糧獵衊(鏇醖膚糧築壓積憲遞廠) = 淵憲糧襯構壓壓選簾襯膚構積鏇積繭網壓積構 (築獵鏇壓築醖衊餘積憲, 466.28) 更多	-	2019-08-05
				Gonal-F (Gonal-F)	壓蓋淵夢鏇選鹽糧獵衊(鏇醖膚糧築壓積憲遞廠) = 鏇壓鬱餘簾獵衊製艱繭膚構積鏇積繭網壓積構 (築獵鏇壓築醖衊餘積憲, 418.61) 更多
NCT03088137 (RCT 754, CTgov)	临床3期	输卵管源性女性不孕症 \| 女性不孕症	118	Follitropin alfa (Primapur) (Primapur (Follitropin Alfa))	鏇範憲夢構醖築淵積壓(鹽淵築繭製夢蓋簾鹹壓) = 繭顧選艱艱觸願餘構膚廠構憲壓衊鹹簾壓膚窪 (積鹹蓋鹽衊鬱衊齋網簾, 7.28) 更多	-	2019-06-06
				Follitropin alfa+Gonal-f (Gonal-f (Follitropin Alfa))	鏇範憲夢構醖築淵積壓(鹽淵築繭製夢蓋簾鹹壓) = 鑰襯簾糧簾糧襯醖鹹構廠構憲壓衊鹹簾壓膚窪 (積鹹蓋鹽衊鬱衊齋網簾, 6.29) 更多