Merional(Merional) - 药物靶点：LHCGR_在研适应症：无排卵_专利_临床

概要

基本信息

药物类型

激素

别名

human menopausal gonadotropin( IBSA Institut Biochimique SA)

靶点

LHCGR

作用机制

LHCGR激动剂(促黄体激素/绒毛膜促性腺激素受体激动剂)

治疗领域

内分泌与代谢疾病泌尿生殖系统疾病

在研适应症

无排卵

非在研适应症

特发性低促性腺素性功能减退症多囊卵巢综合征

原研机构

IBSA Institut Biochimique SA

在研机构

Ibsa Farmaceutici Italia Srl

非在研机构

Saudi German Hospitals Group

最高研发阶段批准上市

首次获批日期

(2009-03-02),

无排卵

最高研发阶段(中国)-

特殊审评-

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关联

9

项与 Merional 相关的临床试验

NCT04754243 / Recruiting临床4期IIT

A Higher Ovulation and Pregnancy Rates in Patients With Unexplained Infertility After Application of ANTIUI Protocol: A Randomized Multicenter Controlled Study

The new protocol ANTIUI provides good results regarding ovulation and pregnancy rates in patients with unexplained infertility

开始日期2021-03-01

申办/合作机构

Tanta University

IRCT20151013024512N7 / Completed临床2期IIT

A comparison of the effect of intraovarian injection of autologous platelet rich plasma (PRP) versus PRP plus gonadotropin and gonadotropin alone on ovarian rejuvenation in patients with diminished ovarian reserve

开始日期2021-02-15

申办/合作机构-

NCT04537078 / Completed临床3期IIT

Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders

The worldwide prevalence of primary and secondary infertility is estimated at
2% and 10.5%, respectively, among women aged 20-44 years and attempting to conceive. Poor ovarian responders (PORs) involve 9-24% of patients undergoing in-vitro fertilization (IVF). proper tailoring of the ovarian stimulation protocol in order to maximize the number of oocytes collected represents a crucial step for them to eventually conceive.
Recent evidence indicates that in the same menstrual cycle, there are multiple follicular recruitment waves. This coincides with the theory that folliculogenesis occurs in a wave-like fashion. Thus, within a single menstrual cycle, there can theoretically be multiple opportunities for a clinician to collect oocytes, as opposed to the conventional single cohort of antral follicles during the follicular phase.
Utilizing this concept, clinicians have been attempting to retrieve oocytes from poor responders using both the follicular-phase stimulation (FPS) and the luteal-phase stimulation (LPS) protocols to increase the number of oocytes collected shorter within shorter period of time. By increasing the number of the retrieved oocytes collected, a better clinical can be assured since there is a clear relationship between the number of oocytes collected and live birth rates across all female age groups.
which protocol is the most effective remains controversial and the efficacy of PPOS in POR compared with that of conventional protocols is unclear.

开始日期2020-09-01

申办/合作机构-

100 项与 Merional 相关的临床结果

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100 项与 Merional 相关的转化医学

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100 项与 Merional 相关的专利（医药）

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736

项与 Merional 相关的文献（医药）

2024-10-01·Journal of Obstetrics and Gynaecology Research

Luteinizing hormone supplementation with human menopausal gonadotropin versus low dose human chorionic gonadotropin during ovarian stimulation does not affect live birth rates after fresh and frozen embryo transfer

Article

作者: Kim, Sung Tae ; Weinerman, Rachel ; Chung, Rebecca K. ; Fischer, Linnea ; Flyckt, Rebecca

AbstractAimLuteinizing hormone (LH) plays an important role in ovarian follicle maturation. Human menopausal gonadotropin (hMG) or low dose human chorionic gonadotropin (hCG) can provide LH supplementation during in vitro fertilization (IVF) ovarian stimulation, though studies directly comparing their impact on IVF outcomes are limited. The aim of the study was to determine whether LH supplementation with hMG versus low dose hCG during IVF stimulation affects live birth rate.MethodsFresh and frozen embryo transfers (ET) from 2017 to 2021 after standard long or antagonist protocols supplemented with hMG (75–250 IU) or low dose hCG (50–100 IU) during stimulation cycles in our academic center were included. Statistical analysis was performed with T‐tests, Mann–Whitney U tests, Chi‐square, and multiple linear and logistic regression.ResultsFour hundred and sixty eight unique stimulation cycles resulting in 213 fresh and 412 frozen embryo transfers were analyzed. There was a lower mature oocyte yield (10.9 vs. 11.8, p = 0.044) but similar high‐quality blastocyst yield (3.6 vs. 3.9, p = 0.11) for hMG vs low dose hCG. Live birth rates per transfer were comparable for fresh (42% vs. 49%, p = 0.24) and frozen (46% vs. 53%, p = 0.45) embryo transfers. Multiple logistic regressions showed no association between supplemental gonadotropin and live birth for both fresh and frozen embryo transfers.ConclusionFresh and frozen IVF‐ET pregnancy outcomes were comparable after hMG versus low dose hCG supplementation, suggesting flexibility in supplemental LH dosing regimens that may address patient or physician preference or cost concerns.

2024-07-01·International journal of reproductive biomedicine

Significance of FSHR and LHCGR gene polymorphisms on clinical outcomes in gonadotropin-releasing hormone antagonist protocol with freeze-all strategy: A case-control study.

Article

作者: Sandhya Alle, Naga ; Prakash, Jaya ; Murali Krishna, Kota ; Prajapathi, Bansi ; Patel, Ami ; Makwana, Paresh ; Amin, Jayesh

BackgroundFollicle-stimulating hormone receptor (FSHR) and luteinizing hormone/choriogonadotropin receptor (LHCGR) are integral to ovarian function, facilitating follicle development and maturation through their respective hormonal interactions. The influence of receptor polymorphisms on the outcomes of freeze-all cycles remains unclear.ObjectiveThis study investigates the impact of FSHR N680S and LHCGR N312S polymorphisms on clinical outcomes in freeze-all cycles.Materials and MethodsWomen undergoing controlled ovarian stimulation for assisted reproductive technology participated in this study. They were administered a gonadotropin-releasing hormone antagonist protocol, with recombinant follicle-stimulating hormone (rFSH) dosages adjusted according to age, body mass index, antral follicle count, and individual hormonal responses. Additionally, human menopausal gonadotropin dosages were tailored based on the LHCGR N312S genetic variant.ResultsAnalysis revealed no significant differences in age, body mass index, antral follicle count, or marital status across the genotypes of FSHR N680S and LHCGR N312S. However, notable differences were observed in the rFSH dosage required daily and in total among the FSHR polymorphism genotypes. Genotypes of the LHCGR polymorphism correlated with fewer stimulation days. A significant interaction was observed between the 2 polymorphisms concerning total rFSH dosage.ConclusionThe presence of serine in the FSHR polymorphism was associated with higher rFSH dosage requirements. Both FSHR N680S and LHCGR N312S polymorphisms significantly influenced clinical pregnancy and live birth outcomes in freeze-all cycles, underscoring the potential of a pharmacogenomic approach to optimize hormone supplementation in controlled ovarian stimulation protocols during assisted reproductive technology treatments.

2024-05-15·Die Pharmazie

Quality evaluation of highly purified human menopausal gonadotropin preparations by means of gel electrophoresis and mass spectrometry.

Article

作者: Dorrer, V. ; Noe, C. R. ; Noe, M. ; Nebija, D. ; Muqaku, L. ; Marchetti-Deschmann, M.

Human gonadotropins are glycoprotein hormones with a highly complex structure, which demands the application of sophisticated analytical methodologies to assess their quality. The principal objective of this study was a comparative evaluation of gel electrophoretic techniques and mass spectrometry-based methods for the quality study of the two urinary-derived, highly purified, human menopausal gonadotropin preparations, Menopur 75/75 I. U. and Meriofert 75 I. U. Molecular mass (Mr), isoelectric point (pI), and isoform pattern of studied compounds were estimated via SDS-PAGE and 2D gel electrophoresis, whereas matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) was used for the downstream characterization of peptides obtained after in-gel tryptic digestion of selected protein spots. Additionally, for the estimation of the glycosylation pattern of these biologics, the enzymatic release of oligosaccharides was performed, and the isoform pattern was studied. Gel electrophoresis showed a typical electrophoretic behaviour for protein biotherapeutics medicines consisting of extremely complex spot patterns migrating at different masses and pIs. MS analysis proved to be a powerful tool for the identification and detailed characterization of the gonadotropins and the relevant peptides were identified with high sequence coverages. The results of this study are not only useful for the quality assessment of this class of complex biopharmaceuticals but may also serve as a supporting platform for further development of biopharmaceuticals based on modulation of the glycosylation pattern to enhance efficacy or reduce side effects.

100 项与 Merional 相关的药物交易

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研发状态

批准上市

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适应症	国家/地区	公司	日期
无排卵	-	Ibsa Farmaceutici Italia Srl	2009-03-02

未上市

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适应症	最高研发状态	国家/地区	公司	日期
多囊卵巢综合征	药物发现	沙特阿拉伯	Saudi German Hospitals Group	2019-04-01
特发性低促性腺素性功能减退症	药物发现	-	-	2016-04-13

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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


ESPE2022	N/A	软骨-头发发育不良	72	gonadotropin	構壓廠觸憲廠壓獵衊觸(積鬱淵簾獵繭觸糧願遞) = 膚顧醖衊簾壓鏇鬱廠膚簾醖鹽觸獵窪壓壓廠鏇 (顧鹽窪齋餘夢鬱糧糧獵, 48) 更多	-	2022-09-15
				gonadotropin	構壓廠觸憲廠壓獵衊觸(積鬱淵簾獵繭觸糧願遞) = 製製顧廠糧衊憲醖齋壓簾醖鹽觸獵窪壓壓廠鏇 (顧鹽窪齋餘夢鬱糧糧獵, 54) 更多
NCT04537078 (CTgov)	临床3期	女性不孕症	90	Combined Oral Contraceptive+Decapeptyl+Cyclo-Progynova+progesterone+Gonadotropin+Duphaston (the Progestin Primed Double Stimulation Group)	觸窪鏇構鹽鏇齋積願範(鹹艱築簾憲糧築繭窪範) = 積齋選網窪醖構構艱衊憲遞鬱製壓餘蓋蓋鬱遞 (鬱構糧廠網製鹽鬱襯蓋, 積壓窪鹽壓網夢淵鏇廠 ~ 構廠餘憲壓憲繭顧鬱襯) 更多	-	2022-02-17
				Combined Oral Contraceptive+Cetrotide Injectable Product+Decapeptyl+Cyclo-Progynova+progesterone+Chorionic Gonadotropin+Gonadotropin (the Flexible GnRh Antagonist)	淵鬱糧遞艱糧觸襯觸製(醖願繭糧窪簾衊願憲衊) = 夢選選鏇製網簾壓獵繭鏇襯觸廠鹽夢醖獵鬱艱 (膚積範鏇觸窪鬱簾範遞, 醖淵範襯遞鬱製願獵夢 ~ 鬱糧選範鏇襯鹹簾蓋製) 更多