A Multicenter, Randomized, Double-blind, Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Human Follicle-stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for Injection in Idiopathic Hypogonadotropin Hypogonadism

This study was conducted to evaluate recombinant human follicle stimulating hormone-CTP fusion protein injection or placebo combined with chorionic gonadotropin for injection

Start Date20 Sep 2024

Sponsor / Collaborator

Changchun Genescience Pharmaceuticals Co., Ltd.

CTR20243077 / RecruitingPhase 3

一项在14至18岁青少年男性特发性低促性腺激素性性腺功能减退症（IHH）中评估重组人促卵泡激素-CTP融合蛋白注射液（rhFSH-CTP）或安慰剂联合注射用绒促性素（hCG）启动或恢复青春期的疗效和安全性的多中心、随机双盲、III期临床研究

[Translation] A multicenter, randomized, double-blind, phase III clinical study to evaluate the efficacy and safety of recombinant human follicle-stimulating hormone-CTP fusion protein injection (rhFSH-CTP) or placebo combined with injectable chorionic gonadotropin (hCG) in initiating or resuming puberty in adolescent males aged 14 to 18 years with idiopathic hypogonadotropic hypogonadism (IHH)

主要目的是在中国14至18岁青少年男性IHH中评估GenSci094联合hCG给药启动或恢复青春期的疗效；次要目的是评估GenSci094联合hCG给药在除睾丸体积外其他青春期启动或恢复方面的疗效，评估GenSci094的药代动力学（PK）特征、安全性、免疫原性。

[Translation]

The primary objective is to evaluate the efficacy of GenSci094 combined with hCG administration in initiating or resuming puberty in Chinese adolescent males aged 14 to 18 years with IHH; the secondary objective is to evaluate the efficacy of GenSci094 combined with hCG administration in other aspects of puberty initiation or resuming except testicular volume, and to evaluate the pharmacokinetic (PK) characteristics, safety, and immunogenicity of GenSci094.

Start Date11 Sep 2024

Sponsor / Collaborator

Changchun Genescience Pharmaceuticals Co., Ltd.

CTR20240265 / RecruitingPhase 3

一项在进行辅助生殖技术（ART）的中国女性患者中比较GenSci094和果纳芬®远期安全性的II/III期延展性研究

[Translation] A Phase II/III extension study comparing the long-term safety of GenSci094 and GONAL-F® in Chinese women undergoing assisted reproductive technology (ART)

收集我司已完成的GenSci094 II期临床试验（方案编号：GenSci2021094II）及正在进行的III期临床试验（方案编号：GenSci094-301）中达到持续妊娠的受试者最终妊娠结局及新生儿情况

[Translation]

Collect the final pregnancy outcomes and neonatal conditions of subjects who have achieved sustained pregnancy in our completed Phase II clinical trial of GenSci094 (Protocol No.: GenSci2021094II) and the ongoing Phase III clinical trial (Protocol No.: GenSci094-301)

Start Date01 Mar 2024

Sponsor / Collaborator

Genekey Biotech (Chengdu) Co. Ltd.

[+1]

100 Clinical Results associated with Human Follicle Stimulating Hormone-CTP Fusion Protein(Xinlitai (Genekey Biotech)

100 Translational Medicine associated with Human Follicle Stimulating Hormone-CTP Fusion Protein(Xinlitai (Genekey Biotech)

100 Patents (Medical) associated with Human Follicle Stimulating Hormone-CTP Fusion Protein(Xinlitai (Genekey Biotech)

Literatures (Medical) associated with Human Follicle Stimulating Hormone-CTP Fusion Protein(Xinlitai (Genekey Biotech)

01 Mar 2024·Reproductive BioMedicine Online

Oocyte in-vitro maturation primed with letrozole-HCG versus FSH-HCG in women with oocyte maturation abnormalities: a retrospective study

Article

Author: Tan, Seang Lin ; Hatirnaz, Ebru ; Calıskan, Canan Soyer ; Hatirnaz, Kaan ; Hatirnaz, Safak ; Celik, Samettin ; Dahan, Michael H ; Urkmez, Sebati Sinan ; Cao, Mingju

RESEARCH QUESTIONAre there differences between in-vitro maturation (IVM) primed with letrozole-human chorionic gonadotrophin (HCG) and IVM primed with FSH-HCG in women with oocyte maturation abnormalities (OMAs), defined as at least two failed IVF cycles where immature oocytes were retrieved?DESIGNThis retrospective study was conducted at a private fertility clinic from January 2009 to April 2023. The final analysis included 75 women in Group 1 (IVM primed with FSH-HCG) and 52 women in Group 2 (IVM primed with letrozole-HCG).RESULTSA significantly higher median number of oocytes was obtained in Group 1 compared with Group 2 {9 [interquartile range (IQR) 1-5] versus 5 (IQR 1-18); P < 0.001}. However, no differences in oocyte maturation stage at collection were found between the groups (P > 0.05). At the end of IVM, Group 1 had 73/666 mature oocytes and Group 2 had 106/322 mature oocytes, and the median metaphase II oocyte rate per patient was higher in Group 2 [33.3% (IQR 66.7-100.0%) versus 0.0% (IQR 0.0-22.2%); P < 0.001]. Moreover, Group 2 demonstrated a higher median fertilization rate [66.7% (IQR 50.0-100.0%) versus 50.0% (IQR 0.0-66.7%); P = 0.027]. Group 2 had a higher proportion of Grade 2 embryos (58.5% versus 6.3%), and Group 1 had a higher proportion of Grade 3 embryos (93.8% vs 24.4%; P < 0.001). Notably, all pregnancies obtained in the study were in Group 2 (5 versus 0; P = 0.042).CONCLUSIONSIVM primed with letrozole-HCG in women with prior failed IVF cycles due to OMAs may result in mature oocytes, clinical pregnancies and live births. The effectiveness of letrozole priming for the subtypes of OMAs needs further investigation, with studies including greater numbers of cases.

01 Jan 2024·Journal of Assisted Reproduction and Genetics

In vitro evaluation of exocytosis-associated SNARE molecules in human granulosa cells in polycystic ovary syndrome

Article

Author: Sokmensuer, Lale Karakoc ; Zırh, Selim ; Bozdag, Gurkan ; Muftuoglu, Sevda F ; Erol, Suleyman

PURPOSEPatients with polycystic ovarian morphology (PCOM) make up 20% cases for assisted reproductive technology (ART). Folliculogenesis is impaired in PCOS. Signaling molecules are involved in follicle development. Dysregulations of intrafollicular environment and signaling molecules are observed in PCOS. Granulosa cells (GCs) and oocytes secrete molecules into follicular fluid by exocytosis of SNAREs. The aim of this study is to evaluate vesicle transport and vesicle fusion proteins (SNAREs) in GCs from PCOS patients who have undergone IVF treatment.METHODSFollicular fluids were collected from patients who undergo IVF/ICSI with the diagnosis of male factor (n = 10) and PCOS (n = 10) patients. GCs were separated and cultured. Each group of GCs was stimulated with FSH-hCG. The cells were examined under electron microscope. Immunofluorescent labeling was performed on cells for Stx6, SNAP25, StxBP1, FSHr, and KITL. Integrated density was analyzed from images of Stx6, SNAP25, StxBP1, FSHr, and KITL.RESULTSIntercellular communication occurs by signal molecules; Stx6, SNAP25, and StxBP1 fusion proteins involved in exocytosis were decreased in the GCs of PCOS. There was no increase in in vitro stimulation with FSH-hCG either. In the electron microscope, it was observed that exocytosis of the vesicles was disrupted.CONCLUSIONSExocytosis and vesicular dynamics are among the basic physiological functions of human steroidogenic granulosa cells. Follicle development is necessary for production of competent oocytes and ovulation. Understanding the pathophysiology of PCOS at follicular level is important for disease management. According to our findings, deficits in vesicular dynamics of human granulosa cells in may be central to the treatment strategy for PCOS patients.

01 Apr 2019·Reproduction in Domestic Animals

A single injection of corifollitropin alfa supplemented with human chorionic gonadotropin increases follicular recruitment and transferable embryos in the rabbit

Article

Author: Viudes‐de‐Castro, María Pilar ; García‐Domínguez, Ximo ; Más Pellicer, Alba ; Marco‐Jiménez, Francisco ; Vicente, Jose Salvador ; Talaván, Amparo M.

ContentsSuperovulation protocols are designed to achieve maximum embryo yields. Nevertheless, ovarian response control and the quality of obtained embryos are still a challenge. On the other hand, to save the superovulated embryos until their subsequent use, it is usual to cryopreserve them, so it is also crucial to assess their cryotolerance. The aim of this study was to compare the efficacy of a single injection of corifollitropin alfa (FSH‐CTP) alone or supplemented with human chorionic gonadotropin (hCG) and to determine the impact of this stimulation on in vitro and in vivo development of fresh or devitrified embryos. Our outcomes showed that ovulation rate and recovered embryos were significantly increased when hCG was used. In vitro development of fresh and devitrified embryos and survival at birth were not significantly affected by superstimulation treatment. Results of this study suggest that a single injection of long‐acting FSH‐CTP supplemented with hCG can be effectively used in rabbits to elicit an increase in ovulation rate and number of recovered embryos. Furthermore, we demonstrated that hCG supplementation had no negative effects in embryo cryosurvival and development, showing similar survival rate at birth than FSH‐CTP alone group.

100 Deals associated with Human Follicle Stimulating Hormone-CTP Fusion Protein(Xinlitai (Genekey Biotech)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Infertility, Female	NDA/BLA	CN	Changchun Genescience Pharmaceuticals Co., Ltd.	18 Jul 2024
Idiopathic Hypogonadotropic Hypogonadism	Phase 3	CN	Changchun Genescience Pharmaceuticals Co., Ltd.	11 Sep 2024
Infertility, Male	Phase 1	CN	Changchun Genescience Pharmaceuticals Co., Ltd.	19 Sep 2023

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