AS 900672-Enriched(AS 900672-Enriched) - 药物靶点：FSHR_专利_临床

概要

基本信息

药物类型

激素

别名

FSH analogue、Follicle-stimulating hormone analogue、Glycosylated recombinant FSH

+ [3]

靶点

FSHR

作用机制

FSHR激动剂(卵泡刺激素受体激动剂)、卵泡刺激

治疗领域

泌尿生殖系统疾病

在研适应症-

非在研适应症

不孕

原研机构

Merck Serono SA

在研机构-

非在研机构

Merck KGaA

最高研发阶段终止临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 AS 900672-Enriched 相关的临床试验

NCT00553514

/ Terminated临床2期

A Phase II, Multicentre, Randomised, Assessor-blinded, Active-comparator, Parallel-group Dose Finding Trial to Evaluate AS900672-enriched Versus Follitropin Alfa (GONAL-f®) in Oligo-anovulatory Infertile Women Undergoing Ovulation Induction (OI)

This is a Phase 2, interventional, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in oligo-anovulatory women undergoing ovulation induction (OI). This study will compare 4 doses of the investigational drug versus a currently marketed drug follitropin alfa (Gonal-f ®) prefilled pen with regards to ovulation rate.

开始日期2007-12-01

申办/合作机构

Merck KGaA

NCT00505752

/ Completed临床2期

A Phase II, Multicenter, Randomized, Assessor-blinded, Active-comparator, Dose-finding Study to Evaluate AS900672 Enriched Versus Follitropin Alfa (Gonal-f®) in Stimulating Multiple Follicular Development in Infertile Women Undergoing Assisted Reproductive Technology (ART)

This is a Phase 2, interventional, prospective, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in infertile women who are undergoing an assisted reproductive technology (ART) procedure (In vitro fertilization/Intra cytoplasmic sperm injection [IVF/ICSI]). This study will compare 3 doses of the investigational drug versus a currently marketed drug follitropin alfa (Gonal-f® revised formulation female [RFF] Pen) in regards to the number of fertilized oocytes.

开始日期2007-01-01

申办/合作机构

Merck KGaA

100 项与 AS 900672-Enriched 相关的临床结果

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100 项与 AS 900672-Enriched 相关的转化医学

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100 项与 AS 900672-Enriched 相关的专利（医药）

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69

项与 AS 900672-Enriched 相关的文献（医药）

2024-12-01·Journal of Assisted Reproduction and Genetics

Effect of follicle-stimulating hormone dose on the risk of being classified as suboptimal responders according to the POSEIDON criteria

Article

作者: Yarali, Hakan ; Vuong, Lan N ; Hochberg, Alyssa ; Esteves, Sandro C ; Dahan, Michael H

PURPOSEThe purpose of this study is to investigate the impact of daily follicle-stimulating-hormone (FSH) dose on the likelihood of suboptimal response to ovarian stimulation (OS) for in vitro fertilization (IVF) according to POSEIDON's criteria.METHODSA tri-center retrospective cohort study (2015-2017) including women with normal anti-Müllerian hormone (AMH ≥ 1.2 ng/mL) and antral follicle count (AFC ≥ 5) values per POSEIDON's criteria, undergoing their first IVF/ICSI cycle using conventional OS (FSH ≥ 150 IU/day). Suboptimal response was the retrieval of 4-9 oocytes. In previous research, we detected an AMH ≤ 2.97 ng/mL and AFC ≤ 12 as the optimal cut-offs predicting suboptimal response. Therefore, we examined the effect of daily FSH dose (≤ 300 IU versus > 300 IU) on suboptimal response risk for each AMH and AFC value within these thresholds (AMH between 1.20 and 2.97 ng/mL, by 0.01 ng/mL increments; and an AFC between 5 and 12, by unit increments). Analysis involved contingency tables and multivariable logistic regression.RESULTSIncluded were 4005 patients with AMH and AFC values in the specific range, among whom 2131 (53.2%) were suboptimal responders. Among 177 AMH groups analyzed, apart from three distributed irregularly, daily FSH doses > 300 IU versus lower doses (≤ 300 IU) did not decrease suboptimal response risk; similarly, higher doses did not decrease risk at the eight AFC values examined (p > 0.05 for all). Using multivariable logistic regression, FSH doses were not associated with suboptimal response risk. Conversely, female age, AMH, AFC, and gonadotropin type were associated with suboptimal response.CONCLUSIONSIn women with AMH values between 1.20 and 2.97 ng/mL and/or AFC between 5 and 12, FSH dose increase did not decrease suboptimal response risk. Individualizing the gonadotropin regimen and considering LH activity supplementation to FSH may mitigate risks.

2024-06-01·Reproduction in Domestic Animals

Association between metabolic parameters and embryo production in superovulated dairy cattle

Article

作者: Tirpan, Mehmet Borga ; Erişek, Abdülkadir ; Coşkun, Muhammed İkbal ; Satilmiş, Muharrem ; Ünay, Engin ; Yilmaz, Mehmet Ali ; Okuroğlu, Alaeddin ; Ünal, İlker ; Kaya, Ufuk ; Say, Erkan ; Sevgi, Ramazan

AbstractThis study aims to investigate the relationship between metabolic parameters and the number of embryos produced in superovulated cows with high genetic characteristics in milk yield. Eighteen Holstein donors were treated with classic superovulation protocols, AI and flushing. During superovulation, decreasing doses of FSH (follicle‐stimulating hormone) were administered at 12‐h intervals for 4 days. Plasma insulin‐like growth factor (IGF1), glucose (GLU), beta‐hydroxybutyric acid (BHB), non‐esterified fatty acid (NEFA), blood urea nitrogen (BUN) and total protein (TP) levels were determined by using an autoanalyzer. The mixed model analysis of variance was used for statistical analysis. As a result, plasma IGF1, BHB and BUN had significant interactions with both groups and days (p < .05). Additionally, plasma TP–days interactions were significant (p < .05). Furthermore, there was a negative correlation between the number of embryos and plasma BHB levels (p < .05). In conclusion, under appropriate environmental conditions, metabolic profile control of donors can contribute to the embryo production process and to the studies on the metabolic infrastructure.

2024-03-01·Arteriosclerosis, Thrombosis, and Vascular Biology

FSH Is Responsible for Androgen Deprivation Therapy–Associated Atherosclerosis in Mice by Exaggerating Endothelial Inflammation and Monocyte Adhesion

Article

作者: Du, Yiqing ; Wang, Qiang ; Geng, Xueyu ; Liang, Zhenhui ; Yao, Weijuan ; Xu, Tao ; Zhou, Jing ; Han, Jingli

BACKGROUND:Androgen deprivation therapy (ADT) is the mainstay treatment for advanced prostate cancer. But ADTs with orchiectomy and gonadotropin-releasing hormone (GnRH) agonist are associated with increased risk of cardiovascular diseases, which appears less significant with GnRH antagonist. The difference of follicle-stimulating hormone (FSH) in ADT modalities is hypothesized to be responsible for ADT-associated cardiovascular diseases.METHODS: We administered orchiectomy, GnRH agonist, or GnRH antagonist in male ApoE−/− mice fed with Western diet and manipulated FSH levels by testosterone and FSH supplementation or FSH antibody to investigate the role of FSH elevation on atherosclerosis. By combining lipidomics, in vitro study, and intraluminal FSHR (FSH receptor) inhibition, we delineated the effects of FSH on endothelium and monocytes and the underlying mechanisms. RESULTS:Orchiectomy and GnRH agonist, but not GnRH antagonist, induced long- or short-term FSH elevation and significantly accelerated atherogenesis. In orchiectomized and testosterone-supplemented mice, FSH exposure increased atherosclerosis. In GnRH agonist–treated mice, blocking of short FSH surge by anti-FSHβ antibody greatly alleviated endothelial inflammation and delayed atherogenesis. In GnRH antagonist–treated mice, FSH supplementation aggravated atherogenesis. Mechanistically, FSH, synergizing with TNF-α (tumor necrosis factor alpha), exacerbated endothelial inflammation by elevating VCAM-1 (vascular cell adhesion protein 1) expression through the cAMP/PKA (protein kinase A)/CREB (cAMP response element-binding protein)/c-Jun and PI3K (phosphatidylinositol 3 kinase)/AKT (protein kinase B)/GSK-3β (glycogen synthase kinase 3 beta)/GATA-6 (GATA-binding protein 6) pathways. In monocytes, FSH upregulated CD29 (cluster of differentiation 29) expression via the PI3K/AKT/GSK-3β/SP1 (specificity protein 1) pathway and promoted monocyte-endothelial adhesion both in vitro and in vivo. Importantly, FSHR knockdown by shRNA in endothelium of carotid arteries markedly reduced GnRH agonist–induced endothelial inflammation and atherosclerosis in mice.CONCLUSIONS:FSH is responsible for ADT-associated atherosclerosis by exaggerating endothelial inflammation and promoting monocyte-endothelial adhesion.

100 项与 AS 900672-Enriched 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
不孕	临床2期	美国	Merck KGaA	2007-01-01
不孕	临床2期	美国	Merck KGaA	2007-01-01

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临床结果

适应症

分期

评价

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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


NCT00553514 (CTgov)	临床2期	不孕	71	Recombinant human chorionic gonadotropin (r-hCG)+AS900672-Enriched 10 microgram (mcg)+Follitropin alfa 75 international unit (IU) (AS900672-Enriched 10 Mcg)	範襯選鹽餘願鏇鏇製鹹(蓋窪淵壓夢遞餘蓋夢遞) = 糧範網淵膚鏇艱艱淵壓襯鹹窪築憲願齋廠憲範 (鏇構蓋鹽築製鹹廠壓鑰, 鹹製鹹構壓願廠繭構獵 ~ 範製淵鏇艱淵廠觸製選) 更多	-	2013-07-25
				Recombinant human chorionic gonadotropin (r-hCG)+AS900672-Enriched 20 mcg+Follitropin alfa 75 international unit (IU) (AS900672-Enriched 20 Mcg)	範襯選鹽餘願鏇鏇製鹹(蓋窪淵壓夢遞餘蓋夢遞) = 淵齋獵襯淵願鹽憲獵遞襯鹹窪築憲願齋廠憲範 (鏇構蓋鹽築製鹹廠壓鑰, 餘鬱鑰製選廠簾獵衊襯 ~ 選築壓範憲餘遞觸餘膚) 更多
NCT00505752 (CTgov)	临床2期	不孕	520	Recombinant human chorionic gonadotropin (r-hCG)+AS900672-Enriched 50 microgram (mcg)+Follitropin alfa 150 international unit (IU) (AS900672-Enriched 50 Mcg)	積積鬱遞憲憲願襯鏇遞(淵艱壓觸蓋顧築繭壓獵) = 範簾廠鬱願網構簾範獵齋糧鹹醖願糧遞鹽鹽獵 (衊積糧憲積鏇醖鹹艱築, 鹹範選製襯淵衊遞遞獵 ~ 觸顧願窪鬱襯餘淵醖鬱) 更多	-	2013-07-24
				Recombinant human chorionic gonadotropin (r-hCG)+Follitropin alfa 150 international unit (IU) (Follitropin Alfa 150 IU)	積積鬱遞憲憲願襯鏇遞(淵艱壓觸蓋顧築繭壓獵) = 膚糧鹹鏇餘糧鑰觸製願齋糧鹹醖願糧遞鹽鹽獵 (衊積糧憲積鏇醖鹹艱築, 觸鬱蓋糧艱選夢選窪願 ~ 壓艱鑰顧顧齋鬱襯膚鹽) 更多