Breastfeeding has well-established immunity and developmental benefits for newborns, yet mothers of preterm infants often struggle to provide sufficient breast milk. The investigators hypothesize that supplementing mothers of preterm infants with nicotinamide riboside (NR) during early postpartum will result in increased milk production. NR is a unique precursor to NAD+, which functions in whole-body metabolism, including that which supports the elevated energy demands of lactation. In lactating rats, NR supplementation improved milk quantity and quality, with metabolic benefits for the mother and lasting protective advantages for the offspring. No studies have been conducted to date that explore the short- or long-term use of NR for increasing milk supply in lactating women. This study will follow a small cohort of women and very preterm infants in the NICU throughout two intervention phases-- one in which each mother will randomly receive either NR or a placebo, then the opposite treatment-- to determine the effect of maternal NR supplementation on expressed milk volume and other markers of metabolism.

开始日期2024-12-01

申办/合作机构

University of California, Davis

NCT06533865 / Not yet recruiting临床3期IIT

Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Adolescents and Young Adults With Functional Hypothalamic Amenorrhea

The goal of this study is to determine whether romosozumab will improve bone density in girls and women with functional hypothalamic amenorrhea (cessation of the menstrual period due to intense exercise, stress, or an eating disorder) who have low bone density. Participants will be randomly assigned to receive romosozumab or placebo for 6 months. All participants will receive one IV infusion of zoledronate at the 6 month visit. All participants will also receive transdermal estradiol and cyclic progesterone. We will investigate whether participants who receive active romosozumab will demonstrate greater improvements in bone density at one year than those who receive placebo. We will also compare bone density over a year with healthy controls (girls and women of similar age who have regular menstrual periods).

开始日期2024-10-01

申办/合作机构-

NCT06396338 / RecruitingN/AIIT

Voluntary Surgical Terminations of Pregnancy: Comparison of the Hemorrhagic Risk Depending on the Term, Between 10 and 14 Weeks of Amenorrhea or Between 14 and 16 Weeks of Amenorrhea

Voluntary termination of pregnancy (abortion) is a major current societal issue. This is a very common situation, around 225,000 abortions are carried out every year in France. The legislation has recently been amended, with the law of March 2, 2022 aimed at strengthening the right to abortion (no. 2022-295) which extended the legal period for voluntary termination of pregnancy from 14 to 16 weeks amenorrhea (AS).
The National College of French Obstetrician Gynecologists (CNGOF), in a press release published on October 12, 2020 in response to the proposed law adopted by the National Assembly, wishes to draw attention to the fact that the procedure of surgical abortion between 14 and 16 AS changes nature. He states that additional procedures are necessary beyond 14 weeks, which could be a source of complications. In addition, the practice recommendations have not been updated following this extension of time, the centers performing abortions are therefore free regarding the protocol for carrying out these so-called late abortions (between 14 and 16 weeks).
There are two pregnancy termination techniques practiced in France: medical or surgical.
Due to the recent nature of these late abortions, practitioners still have little experience of the consequences of these procedures and this compromises the quality of the information provided to patients. It is necessary to have quality studies to improve knowledge about late-term abortions, in order to be able to correctly inform patients and allow them to make an informed choice regarding the method used.
This study follows the modification of the legislation extending the legal period for abortion, with the aim of providing arguments regarding the safety of carrying out surgical abortions at these more advanced stages of pregnancy.
In addition, abortion often generates anxiety, the term at which it is carried out could influence the experience of patients. This study would therefore also improve knowledge about the experience of abortion, in order to better support patients throughout their journey.

开始日期2024-09-01

申办/合作机构

Toulouse University Hospital

100 项与闭经相关的临床结果

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100 项与闭经相关的转化医学

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0 项与闭经相关的专利（医药）

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13,075

项与闭经相关的文献（医药）

2024-12-31·Journal of Obstetrics and Gynaecology

Primary amenorrhoea - cytogenetic study in 40 Indian women

Article

作者: Halder, Ajanta ; Banerjee, Byapti ; Dutta, Atreyee ; Roy, Sanchita

BACKGROUNDPrimary amenorrhoea (PA) refers to an ailment when adolescent girls do not attain menarche naturally. It is one of the most common gynaecological disorders specified. Chromosomal abnormalities play a pivotal role in PA. Cytogenetic analysis is an indispensable diagnostic tool to determine the abnormality of the chromosome. In an emerging country like India, cytogenetic analysis is at a nascent stage. There are very few studies on Cytogenetics present in eastern India, including West Bengal. In rural and suburban areas PA sufferers often experience late diagnosis and struggle to access suitable curative management. The aim of the study is to evaluate the various types of chromosomal abnormalities in patients suffering from PA for accurate, better management of the same and further counselling.METHODSA total of 40 PA cases were referred by obstetricians and gynaecologists to the Department of Genetics of Nirnayan Health Care, Kolkata. To screen the chromosomal abnormalities, human leukocyte culture was accomplished with their peripheral venous blood followed by G-banding and then karyotyping was executed according to ISCN-2020.RESULTOut of 40 patients, 29 were normal among which 46,XX was found in 70% cases (n = 28) and 46,XX,9qh + in 2.5% (n = 1). The remaining 11 showed different types of abnormalities. 45,X was found in 10% (n = 4), 46,X,i(X)(q10) in 2.5% (n = 1), 46,X,del(X)(p11.2) in 2.5% (n = 1), 46,X,del(X)(p22.1) in 2.5% (n = 1), 46,X,del(X)(q24) in 2.5% (n = 1), 46,XY in 2.5% (n = 1), mos 45,X[22]/46,Xi(X)(q.10)[8] in 2.5% (n = 1) and mos 45,X[16]/46,XY[14] (2.5%) in 2.5% (n = 1).CONCLUSIONThis study indicates the importance of chromosomal study which must be included in early diagnosis of PA. Karyotyping at the appropriate phase of life will not only help in the judicial management of this disorder but will also give young girls a better lifestyle.

2024-12-31·Journal of Psychosomatic Obstetrics & Gynecology

Analysis of the effects of eating and emotions on reproductive axis function in patients with functional hypothalamic amenorrhea

Article

作者: Zhang, Feifei ; Chen, Yao ; Zhao, Yuting ; Wang, Yulu ; Lu, Ye ; Chen, Hang ; Li, Xin

Objective: To investigate the effects of eating and emotions on reproductive axis function in patients with functional hypothalamic amenorrhea (FHA).Methods: A retrospective cohort study was conducted to summarize the clinical and endocrine characteristics of 58 patients with FHA at initial diagnosis and to follow up the recovery of ovulation and spontaneous menstruation in the patients to investigate these biochemical indicators and their effects on recovery outcomes.Results: Among patients with FHA, 13.8% (8/58) and 15.5% (9/58) had above moderately severe depressive and severe anxiety symptoms respectively, and 25.9% (15/58) were at high risk for eating disorders. 34.5% (20/58) were included assessed as having recovered. The non-recovered group had higher scores on the Patient Health Questionnaire (PHQ-9) (p = .022) and higher scores on the Eating Attitude Test-26 (EAT-26) (p = .03) as well as bulimia and food preoccupation (p = .041). Follicle diameter >5 mm at initial diagnosis was an independent factor influencing recovery of reproductive axis function (odds ratio = 7.532; 95% confidence interval, 1.321-42.930; p = .023).Conculsions: Mood disorders and a certain risk of eating disorders were present in FHA.These, together with weight loss, endocrine and follicle size, could influence the outcome.

2024-12-31·Gynecological Endocrinology

Menstrual pattern in polycystic ovary syndrome and hypothalamic-pituitary-ovarian axis immaturity in adolescents: a systematic review and meta-analysis

Review

作者: Soares, José M ; Zuchelo, Lea T S ; Baracat, Edmund C ; Sorpreso, Isabel C E ; Alves, Mayara S

OBJECTIVETo analyze differences in the menstrual pattern, age at menarche, and body mass index (BMI) in adolescents with Hypothalamic-Pituitary-Ovarian (HPO) axis immaturity and Polycystic Ovary Syndrome (PCOS) through a systematic review and meta-analysis.METHODSThe PubMed, EMBASE, Web of Science, Virtual Health Library, Scopus databases were searched using combinations of descriptors. Study quality was assessed using the Newcastle-Ottawa Scale. For data analysis, the results were grouped into PCOS group and NPCOS group (HPO axis immaturity). We performed a meta-analysis of raw data and the inverse variance method, employing the standardized mean difference, of the age at menarche and BMI of adolescents.RESULTSParticipants totaled 1,718 from nine selected studies. The meta-analysis showed that the PCOS group had a higher BMI than the NPCOS group (SMD 0.334; CI95% 0.073 - 0.595; p = .012). The degree of heterogeneity of the studies was approximately 40%. No significant difference in age at menarche (SMD - 0.027; CI95% -0.227 - 0.172; p = 0.790) and menstrual patterns was found, but amenorrhea was described only in adolescents with PCOS.CONCLUSIONSThe main characteristic in menstrual pattern that differentiated PCOS patients from girls with HPO axis immaturity was amenorrhea. Also, the BMI of PCOS patients was nearly one third higher than that of adolescents with HPO axis immaturity.

项与闭经相关的新闻（医药）

2024-09-28

·药通社

20亿激素类“珠穆朗玛峰”，迎来国产第3家！

说起痛经，大部分女孩子都不会陌生，每个月总有那么几天浑身不适、下腹坠胀、腰酸背痛，严重的人群还可能出现恶心、呕吐、腹泻、头晕、乏力等不适症状。据统计，痛经的发生率可以高达45.3%-90%。对广大女性的身心健康都造成了重大影响，甚至还会增加肥胖、偏头痛、抑郁、焦虑、睡眠障碍等病理情况的发生率。地屈孕酮（Dydrogesterone）是一种口服孕激素，用于治疗内源性孕酮不足引起的疾病，是一种性激素及生殖系统调节剂。主要用于治疗内源性孕酮不足，如子宫内膜异位症、功能失调性子宫出血、痛经、习惯性流产、经前期综合征、继发性闭经、孕激素缺乏所致先兆性流产等症状。据悉，地屈孕酮为结构和功能最接近天然孕激素的一种合成孕激素，与天然孕激素黄体酮相比，其生物利用度更高、给药频率更低且肝脏安全性更优；与传统合成孕激素相比，其无雌激素、雄激素和皮质激素作用，不增加乳腺癌的发生风险。目前其已被中国《闭经诊断与治疗指南（2023版）》、中国《子宫内膜异位症诊治指南（第三版）（2021）》、中国《孕激素维持妊娠与黄体支持临床实践指南（2021）》和日本《临床实践指南：子宫内膜异位症（第3版）（2022）》等国内外权威指南推荐广泛用于多种妇产科疾病。地屈孕酮片由雅培研发并生产，1961年首次面世，2002年进入中国市场，为国家医保乙类品种，商品名为「达芙通」。目前已在全球100多个国家获批上市。由于其合成工艺复杂，技术门槛高，被称作激素类药物的“珠穆朗玛峰”，所以几十年来全球罕有仿制药上市。根据米内网数据，近年来地屈孕酮片国内市场持续扩容，2023年在中国三大终端六大市场的销售额超过20亿元，其中原研厂家雅培占据99.86%的市场份额。中国三大终端六大市场地屈孕酮片销售情况（单位：万元）（来源：米内网数据库）日前，科伦药业（002422）发布公告称，公司化学药品“地屈孕酮片”于近日获得国家药品监督管理局的药品注册批准。并表示，生殖健康为公司的重点核心领域，目前公司在该领域已有多个产品获批上市，本次地屈孕酮片为国产第3家获批，这将进一步提升公司在生殖健康领域的管线竞争力。作为一款常用的孕激素制剂，地屈孕酮片技术壁垒高，市场想象空间巨大。截至目前，国内已有奥锐特药业、和泽坤元药业以及科伦药业3家药企拥有地屈孕酮片的生产批文。此外，浙江仙琚制药、浙江赛默制药、浙江爱生药业等企业也已经提交了地屈孕酮片的上市申请，处于审批审批阶段，国产替代有望进一步加速。来源：药春秋投稿/内容沟通：华籍美人（Ww_150525）近期精华文章

上市批准

2024-08-23

·美通社

喜报 | 易浦润（上海）生物技术有限公司佩朵®硅橡胶子宫药物支架系统获批

中国原研 · 世界首创上海 2024年8月23日 /美通社/ -- 近日，易浦润（上海）生物技术有限公司研发的佩朵 ® 硅橡胶子宫药物支架系统获得国家药品监督管理局（NMPA）注册批准（国械注准20243181461）。该产品用于中、重度宫腔粘连患者进行宫腔镜宫腔粘连松解术后的宫腔放置，辅助预防宫腔再粘连。产品注册临床为随机对照试验(RCT)，相比较于临床指南推荐的常规治疗方案，该产品临床试验结果达到优效设计，系一款"中国原研、世界首创"的产品，可优效促进子宫内膜生长，预防宫腔粘连，保护女性生育力，关注全球女性健康，为临床提供全新更优的治疗选择。宫腔粘连(intrauterine adhesions，IUA)是因子宫内膜基底层损伤引发的子宫肌壁相互粘连，以致宫颈管、子宫腔部分或全部闭塞。临床上可引起一系列月经量减少、闭经、不孕以及反复流产等症状，严重危害育龄女性的生殖生理健康。目前，IUA在我国的发病率居高不下，并且随着宫腔手术的增加呈逐年增长趋势。文献报道，多次人工流产、刮宫所致的IUA发生率高达25%～30%，已经成为月经量减少、继发不孕的主要原因 [1] 。宫腔镜下宫腔粘连松解术(transcervical resection of adhesions，TCRA)作为治疗IUA的标准手术方法，可有效分离粘连组织，恢复宫腔解剖学形态。据相关数据调研，该类型手术在中国每年高达160～180万台，但术后IUA复发率仍高达62.5% [2] ，TCRA术后的患者妊娠成功率仅22.5%～33.3% [3-4] 。多年来，TCRA 术后常规采用多种辅助治疗措施，如子宫腔隔离屏障材料、人工激素周期等疗法，但治疗效果仍有一定局限性。佩朵 ® 硅橡胶子宫药物支架系统是一款创新的药械组合产品，由非降解的医用级材料和雌激素组成。产品贴合子宫形状设计，置入后的材料可提供完整的物理阻隔，同时实现宫腔内靶向释放雌激素，直接作用于子宫内膜部位，在置入宫腔的60天内，通过公司特有的控释技术，持续释放雌激素，优效促进子宫内膜生长。佩朵®置于宫腔内，提供完整物理阻隔的同时，能够在宫内持续释放雌激素药物佩朵 ® 硅橡胶子宫药物支架系统的注册临床试验显示，相比较于指南推荐的临床常规治疗方案，该产品临床试验结果达到优效设计，在术后60天内膜厚度较基线增厚及术后60天的减少宫腔粘连有效率方面，试验组较对照组，两组间数据具有极显著性统计学差异，临床获益明显，临床试验结果达到优效设计。佩朵®临床试验有效性评价数据参考文献 [1] 2015 Chinese expert consensus on the clinical diagnosis and treatment of intrauterine adhesions [2] Yu D , Wong YM , Cheong Y ,et al. Asherman syndrome: one century later[J]. Fertil Steril, 2008,89(4):759–779. [3] Yu D , Li TC , Xia E ,et al. Factors affecting reproductive outcome of hysteroscopic adhesiolysis for Asherman's syndrome[J]. Fertil Steril, 2008,89(3):715–722. [4] Roy KK , Baruah J , Sharma JB ,et al. Reproductive outcome following hysteroscopic adhesiolysis in patients with infertility due to Asherman's syndrome[J]. Arch Gynecol Obstet, 2010,281(2):355–361. 公司简介易浦润（上海）生物技术有限公司("易浦润")坐落于上海市张江高科技园区，是浦易（上海）生物技术股份有限公司("浦易生物")的全资子公司。依托于生物医用材料转化工艺和先进的药物控释技术，浦易生物与易浦润研发了多个创新管线，储备了多款高端植入介入产品。自2012年成立以来，浦易生物集团持续专注于尚未被满足的临床需求，为女性健康、五官科及消费健康等领域提供创新的解决方案。浦易生物集团的投资者包括高盛另类投资、君联资本和北极光创投等知名投资机构。联系我们地址：中国上海市浦东新区李时珍路396号2206室公司联系电话：86-021-50805520；产品全国招商电话：86-021-58556388 官网： www.puyibio.com 邮箱： service@puyibio.com

临床研究

2024-08-23

·PRNewswire

Corina Intrauterine Drug-Eluting System approved in China as a novel treatment for patients with moderate-to-severe intrauterine adhesions (IUA)

The World's First-in-Class Intrauterine Drug-Eluting System SHANGHAI, Aug. 23, 2024 /PRNewswire/ -- Corina Intrauterine Drug-Eluting System ("Corina"), developed by Yipurun (Shanghai) Biotechnology Co., Ltd. ("YPR"), has received approval in China (G.X.Z.Z. 20243181461) for use in patients with moderate-to-severe intrauterine adhesions (IUA) who undergo transcervical resection of adhesions (TCRA). The approval for this indication is based on a randomized controlled clinical trial that demonstrated Corina's superior efficacy compared to the standard-of-care. Corina is a first-in-class treatment focused on promoting female reproductive health through the prevention of intrauterine re-adhesion risk post TCRA, and the improvement of endometrial growth. Continue Reading Corina acts as a physical barrier upon insertion, and enables targeted delivery of estradiol to the endometrium Evaluating effectiveness data from clinical trials Intrauterine adhesions (IUA) are the formation of scar tissues in the endometrial cavity as a result of damages to the endometrial basal layer of the uterus, which leads to the partial or complete occlusion of the cervical canal and uterine cavity. Clinically, IUA can cause a range of symptoms such as reduced menstrual flow, amenorrhea, infertility and recurrent miscarriage – thereby posing a serious threat to the reproductive health of women of childbearing age. Currently, the incidence rate of IUA in China remains high, and continues to grow due to an increased number of intrauterine interventions. Research in this field show the incidence rate of IUA in China to be as high as 25% in women who have had prior abortion or curettage procedures [1] — this has become a key driver of reduced menstrual flow and secondary infertility in women of childbearing age. As a standard surgical procedure to treat IUA, TCRA separates the adherent tissues and restores the anatomical shape of the uterine cavity. Surveys show 1.6 to 1.8 million patients in China undergo TCRA every year, but the recurrence rate of IUA after surgery is still as high as 62.5% [2]; and the pregnancy success rate of patients after TCRA surgery is only 22.5%~33.3% [3-4]. Over the years, a variety of adjuvant therapies, such as uterine cavity isolation barriers and hormonal treatments, have emerged with limited efficacy. Corina is an innovative drug-device-combination therapy made from non-degradable, medical grade material, carrying the active ingredient estradiol. Designed to conform to the shape of the female uterus, Corina acts as a physical barrier upon insertion, and enables targeted delivery of estradiol to the endometrium. With YPR's proprietary controlled-release technology, Corina can continuously release the active substance up to 60 days post procedure to promote endometrium growth. The registration study results of Corina have demonstrated statistically significant and clinically meaningful reduction in intrauterine adhesion at 60 days post procedure, compared to standard-of-care therapy. Corina has also shown meaningful improvement in endometrial thickness from baseline at 60 days post procedure, compared to standard-of-care therapy. A bout Puyi Biotech Located in the Zhangjiang Hi-Tech Park in Shanghai, Yipurun (Shanghai) Biotechnology Co., Ltd. ('YPR') is a wholly-owned subsidiary of Puyi (Shanghai) Biotechnology Co., Ltd. ("Puyi Biotech" or "Group"). Leveraging its knowhow in biomedical material science and its proprietary drug-eluting technology, Puyi Biotech and YPR have developed an innovative R&D pipeline of high-end implantable therapeutics. Since its founding in 2012, Puyi Biotech has focused on providing innovative solutions to address unmet clinical needs across women's health, ENT (ear, nose and throat), and medical aesthetics categories. The Group has a number of renowned institutions as investors including Goldman Sachs Alternatives, Legend Capital and Northern Light VC. Contact Us Address: Room 2206, No. 396, Lishizhen Road, Pudong New Area, Shanghai, China Company Contact Tel: +86-21-50805520, Merchants Phone: +86-21-58556388 Website: en.puyibio.com Email: [email protected] SOURCE Puyi (Shanghai) Biotechnology Co., Ltd