Comparison of Clomiphene Citrate vs Human Menopausal Gonadotropin for controlled ovarian stimulation in infertile women with decreased ovarian reserve (DOR) - A randomised controlled trial - NIL

Start Date15 Sep 2024

Sponsor / Collaborator-

CTR20242399 / RecruitingPhase 1

比对SJ04注射液与艾泽®在中国健康女性受试者中的药代动力学、安全性和免疫原性的Ⅰ期临床试验

[Translation] Phase I clinical trial comparing the pharmacokinetics, safety and immunogenicity of SJ04 injection and Aize® in healthy Chinese female subjects

主要目的评价SJ04注射液与艾泽®在中国健康女性受试者中单次皮下注射给药后药代动力学（PK）的相似性。次要目的评价SJ04注射液与艾泽®在中国健康女性受试者中单次皮下注射给药后的安全性和免疫原性。

[Translation]

Primary objective To evaluate the pharmacokinetic (PK) similarity between SJ04 injection and Aize® in healthy Chinese female subjects after a single subcutaneous injection. Secondary objective To evaluate the safety and immunogenicity of SJ04 injection and Aize® in healthy Chinese female subjects after a single subcutaneous injection.

Start Date12 Aug 2024

Sponsor / Collaborator

Suzhou Shengji Pharmaceutical Co Ltd

100 Clinical Results associated with FSHR x LHCGR

100 Translational Medicine associated with FSHR x LHCGR

0 Patents (Medical) associated with FSHR x LHCGR

375

Literatures (Medical) associated with FSHR x LHCGR

01 Sep 2024·Journal of Neuroendocrinology

Restoring function to inactivating G protein‐coupled receptor variants in the hypothalamic–pituitary–gonadal axis¹

Review

Author: Newton, Claire L. ; Anderson, Ross C. ; Millar, Robert P. ; Radomsky, Tarryn

AbstractG protein‐coupled receptors (GPCRs) are central to the functioning of the hypothalamic–pituitary–gonadal axis (HPG axis) and include the rhodopsin‐like GPCR family members, neurokinin 3 receptor, kappa‐opioid receptor, kisspeptin 1 receptor, gonadotropin‐releasing hormone receptor, and the gonadotropin receptors, luteinizing hormone/choriogonadotropin receptor and follicle‐stimulating hormone receptor. Unsurprisingly, inactivating variants of these receptors have been implicated in a spectrum of reproductive phenotypes, including failure to undergo puberty, and infertility. Clinical induction of puberty in patients harbouring such variants is possible, but restoration of fertility is not always a realisable outcome, particularly for those patients suffering from primary hypogonadism. Thus, novel pharmaceuticals and/or a fundamental change in approach to treating these patients are required. The increasing wealth of data describing the effects of coding‐region genetic variants on GPCR function has highlighted that the majority appear to be dysfunctional as a result of misfolding of the encoded receptor protein, which, in turn, results in impaired receptor trafficking through the secretory pathway to the cell surface. As such, these intracellularly retained receptors may be amenable to ‘rescue’ using a pharmacological chaperone (PC)‐based approach. PCs are small, cell permeant molecules hypothesised to interact with misfolded intracellularly retained proteins, stabilising their folding and promoting their trafficking through the secretory pathway. In support of the use of this approach as a viable therapeutic option, it has been observed that many rescued variant GPCRs retain at least a degree of functionality when ‘rescued’ to the cell surface. In this review, we examine the GPCR PC research landscape, focussing on the rescue of inactivating variant GPCRs with important roles in the HPG axis, and describe what is known regarding the mechanisms by which PCs restore trafficking and function. We also discuss some of the merits and obstacles associated with taking this approach forward into a clinical setting.

01 Sep 2024·Cell Calcium

Injection of luteinizing hormone or human chorionic gonadotropin increases calcium excretion and serum PTH in males

Article

Author: Juel Mortensen, Li ; Jørgensen, Anne ; Juul, Anders ; Blomberg Jensen, Martin ; Rye Jørgensen, Niklas ; Røder, Andreas ; Andersson, Anna-Maria ; Lorenzen, Mette ; Kooij, Ireen

Animal and human studies have suggested that sex steroids have calciotropic actions, and it has been proposed that follicle-stimulating hormone (FSH) may exert direct effects on bone. Here, we demonstrate the expression of the receptor for Luteinizing hormone (LH) and human choriogonadotropin (hCG), LHCGR, in human kidney tissue, suggesting a potential influence on calcium homeostasis. To investigate the role of LHCGR agonist on calcium homeostasis in vivo, we conducted studies in male mice and human subjects. Male mice were treated with luteinizing hormone (LH), and human extrapolation was achieved by injecting 5000 IU hCG once to healthy men or men with hypergonadotropic or hypogonadotropic hypogonadism. In mice, LH treatment significantly increased urinary calcium excretion and induced a secondary increase in serum parathyroid hormone (PTH). Similarly, hCG treatment in healthy men led to a significant increase in urinary calcium excretion, serum PTH levels, and 1,25 (OH)₂D₃, while calcitonin, and albumin levels were reduced, possibly to avoid development of persistent hypocalcemia. Still, the rapid initial decline in ionized calcium coincided with a significant prolongation of the cardiac QTc-interval that normalized over time. The observed effects may be attributed to LH/hCG-receptor (LHCGR) activation, considering the presence of LHCGR expression in human kidney tissue, and the increase in sex steroids occurred several hours after the changes in calcium homeostasis. Our translational study shed light on the intricate relationship between gonadotropins, sex hormones and calcium, suggesting that LHCGR may be influencing calcium homeostasis directly or indirectly.

01 Sep 2024·Animal Reproduction Science

Epigenetic modifications of gonadotropin receptors can regulate follicular development

Review

Author: Zhang, Ruimen ; Feng, Wanyou ; Shi, Deshun ; Yang, Yanyan ; Lin, Xinyue ; Deng, Yanfei ; Zhou, Jinhua ; Sooranna, Suren Rao

The spatiotemporal transcription of follicle-stimulating hormone receptor (FSHR) and luteinizing hormone/human chorionic gonadotropin receptor (LHCGR) are crucial events for follicular development. However, their regulatory mechanisms are unclear. DNA methylation and histone acetylation are the main epigenetic modifications, and play important roles in transcriptional expression, which regulate cell responses including cell proliferation, senescence and apoptosis. This review will discuss the dynamic epigenetic modifications of FSHR and LHCGR that occur during the process of follicular development and their response to gonadotropins. In addition, some alteration patterns that occur during these epigenetic modifications, as well as their retrospect retrotransposons, which regulate the gene expression levels of FSHR and LHCGR will be discussed.

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