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Development of a Long-Acting Follicle-Stimulating Hormone Using Serum Albumin Fab-Associated Technology for Female Infertility
Daham Kim, Yoon Hee Cho, Min Jeong Kang, So Jeong Lee, Soohyun Lee, Bo Hyon Yun, Hyunjin Chi, Jeongsuk An, Kyungsun Lee, Jaekyu Han, Susan Chi, Moo Young Song, Sang-Hoon Cha, Eun Jig Lee
Endocrinol Metab. 2025;40(1):146-155.   Published online December 4, 2024
DOI: https://doi.org/10.3803/EnM.2024.2090
  • 870 View
  • 60 Download
AbstractAbstract PDFPubReader   ePub   
Background
Recombinant human follicle-stimulating hormone (rhFSH) is commonly used to treat female infertility, but its short half-life necessitates multiple doses. Even corifollitropin alfa, with an extended half-life, requires supplementary injections of rhFSH after 7 days. This study aimed to develop and evaluate a long-acting follicle-stimulating hormone (FSH) formulation using anti-serum albumin Fab-associated (SAFA) technology to avoid additional injections and enhance ovarian function.
Methods
SAFA-FSH was synthesized using a Chinese hamster ovary expression system. Its biological efficacy was confirmed through assays measuring its ability to stimulate cyclic adenosine monophosphate (cAMP) production, estradiol synthesis, and the expression of human cytochrome P450 family 19 subfamily A member 1 (hCYP19α1) and human steroidogenic acute regulatory protein (hSTAR) in human ovarian granulosa (KGN) cells. To evaluate the effects of SAFA-FSH, we compared its impact on serum estradiol levels and ovarian weight increase with that of rhFSH in Sprague-Dawley (SD) rats using the modified Steelman-Pohley test.
Results
The results indicated that SAFA-FSH induces cAMP synthesis in KGN cells and upregulates the expression of hCYP19α1 and hSTAR in a dose-dependent manner. Female SD rats, aged 21 days, receiving daily subcutaneous human chorionic gonadotropin injections for 5 days exhibited a significant increase in serum estradiol levels and ovarian weight when administered SAFA-FSH on the first day or when given nine injections of rhFSH over 5 days. Notably, the group receiving SAFA-FSH on the first and third days demonstrated an even greater rise in serum estradiol levels and ovarian weight.
Conclusion
These findings suggest that SAFA-FSH presents a promising alternative to current rhFSH treatments for female infertility. However, further research is essential to thoroughly assess its safety and efficacy in clinical contexts.
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Thyroid
Thyroid Hormone Reference Intervals among Healthy Individuals In Lanzhou, China
Yan Lu, Wen-Xia Zhang, De-Hong Li, Lian-Hua Wei, Yu-Jun Zhang, Fu-Na Shi, Shen Zhou
Endocrinol Metab. 2023;38(3):347-356.   Published online June 14, 2023
DOI: https://doi.org/10.3803/EnM.2023.1638
  • 4,982 View
  • 176 Download
  • 1 Web of Science
  • 2 Crossref
AbstractAbstract PDFPubReader   ePub   
Background
The common reference intervals (RIs) for thyroid hormones currently used in China are provided by equipment manufacturers. This study aimed to establish thyroid hormone RIs in the population of Lanzhou, a city in the subplateau region of northwest China, and compare them with previous reports and manufacturer-provided values.
Methods
In total, 3,123 individuals (1,680 men, 1,443 women) from Lanzhou, an iodine-adequate area of China, perceived as healthy were selected. The Abbott Architect analyzer was used to determine the serum concentration of thyroid hormones. The 95% RI was estimated using the 2.5th and 97.5th percentiles as the lower and upper reference limits, respectively.
Results
The serum levels of thyroid-stimulating hormone (TSH), total triiodothyronine (TT3), antithyroglobulin (ATG) antibody, and antithyroid peroxidase (ATPO) antibody levels were significantly correlated with sex (P<0.05). TSH, total thyroxine (TT4), and ATPO levels were significantly correlated with age (P<0.05). The serum levels of TSH, ATG, and ATPO in men were significantly lower than in women; in contrast, the serum TT3 level was significantly higher in men than in women (P<0.05). Serum TSH, TT3, TT4, and ATG levels differed across age groups (P<0.05), but no such variation was observed for ATG levels (P>0.05). The established RIs of TSH, ATG, and ATPO in this study differed between sexes (P<0.05). The thyroid hormone RIs established herein were inconsistent with the manufacturer-provided values.
Conclusion
The RIs of thyroid hormones in the healthy population of Lanzhou were inconsistent with those in the manufacturer’s manual. Validated sex-specific values are required for diagnosing thyroid diseases.

Citations

Citations to this article as recorded by  
  • Women-specific reference ranges for serum TSH in Liguria: the impact of age and year of collection in a single-center cross-sectional study
    Massimo Giusti, Marilena Sidoti
    Thyroid Research.2025;[Epub]     CrossRef
  • Burden of non-alcoholic fatty liver disease in subclinical hypothyroidism
    Mahmood Dhahir Al-Mendalawi
    Journal of Clinical and Scientific Research.2024; 13(1): 68.     CrossRef
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Case Report
A Case of Kallmann's Syndrome Mildly Presenting as Secondary Amenorrhea.
Na Rae Joo, Cheol Young Park, Hong Ju Moon, Jun Goo Kang, Sung Hee Ihm, Moon Gi Choi, Hyung Joon Yoo, Yul Lee, Ki Won Oh, Sung woo Park
J Korean Endocr Soc. 2007;22(2):130-134.   Published online April 1, 2007
DOI: https://doi.org/10.3803/jkes.2007.22.2.130
  • 2,535 View
  • 34 Download
AbstractAbstract PDF
Kallmann's syndrome is very rare congenital defect in GnRH (gonadotrophin releasing hormone) secretion involving both sexes. The mode of inheritance has not been fully understood. But, including X-linked inheritance, the ratio of incidence between male versus female is 5:1, and there is a few case reports of female Kallmann's syndrome in Korea, especially in internal medicine department. We report a case of 35 year-old female Kallmann's syndrome presenting secondary amenorrhea as a mild presentation.
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Original Article
Regulation of Prolactin Gene Expression by Hypothalamic Pituitary Adenylate Cyclase-Activating Polypeptide (PACAP) in the Female Rat Pituitary Gland.
Young Il Kim, Tae Young Ha, Eun Sook Kim, Il Seong Nam-Goong, M S O'Dorisio, Min Kyu Hur, Sang Kyu Park
J Korean Endocr Soc. 2004;19(2):152-164.   Published online April 1, 2004
  • 1,213 View
  • 20 Download
AbstractAbstract PDF
BACKGROUND
Pituitary adenylate cyclase-activating polypeptide (PACAP) plays the role of a hypophysiotropic factor, which regulates the synthesis and secretion of pituitary hormones through the hypothalamo-hypophysial portal system. No clear evidence has yet been reported regarding the regulation of prolactin (PRL) by PACAP. In the present study, we tested a hypothesis that PACAP regulates the synthetic machinery of PRL during the estrus cycle and pubertal process using intracerebroventricular (i.c.v.) injection of an antisense oligodeoxynucleotide (ODN) against type I PACAP receptor (PAC1). METHODS: An RNase protection assay (RPA) was used to determine the pattern of hypothalamic PACAP and PAC1 mRNA expressions during the estrus cycle. Antisense PAC1 ODN was administered via i.c.v. injection to the female rats in normal estrus cycle of pubertal process. Northern blot analysis was used to determine the mRNA ievel of PRL in the pituitary gland. RESULTS: 1) PACAP mRNA in the medial basal hypothalamus was significantly increased at the diestrus I, while PAC1 mRNA showed no significant change. 2) PRL mRNA level of pituitary was increased by an injection of antisense PAC1 ODN at the proestrus and estrus stages. 3) PRL mRNA level of pituitary was significantly decreased by antisense PAC1 ODN injection at stage of prepuberty and initiate puberty, while its level was increased at stage of puberty. CONCLUSION: These data suggest that PACAP suppresses PRL mRNA synthesis through the PAC1 signaling pathway in the certain estrus cycle environments. It may be also involved in the regulation of pituitary PRL gene expression during the pubertal process
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