Anti-Mullerian Hormone in the Female Participants of the Multi-Center Study of Hydroxyurea

羟基脲多中心研究女性参与者的抗苗勒氏管激素

• 批准号: 9788509
• 负责人: SOPHIE M LANZKRON
• 金额: $ 12.28万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-15 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9788509
• 关键词: Adolescent; Adult; Affect; Age; Age-Months; Biological Markers; Caring; Cessation of life; Characteristics; Clinical; Collaborations; Cross-Sectional Studies; Data; Developed Countries; Developing Countries; Disease; Disease Marker; Estradiol; Ethics; Evaluation; Evidence based treatment; Exposure to; Female; Female Adolescents; Fertility; Fertility Study; Follicle Stimulating Hormone; Future; Goals; Hematologist; Hemoglobin; Hemolytic Anemia; Hormones; Human; Hypoxia; Impairment; Injury; Knowledge; Measures; Menstrual cycle; Methodology; Multicenter Studies; Mus; Mutation; National Heart, Lung, and Blood Institute; Organ; Ovarian; Ovarian Follicle; Ovary; Ovulation; Participant; Patients; Phenotype; Physicians; Placebo Control; Placebos; Population; Randomized; Research; Research Personnel; Reticulocyte count; Sampling; Seminal; Serum; Severity of illness; Sickle Cell; Sickle Cell Anemia; Sickle Hemoglobin; Time; United States; Woman; Work; arm; career; chemotherapy; cohort; control trial; design; diminished ovarian reserve; folliculogenesis; frontier; fundamental research; girls; hydroxyurea; injured; mullerian-inhibiting hormone; multiorgan injury; ovarian reserve; placebo controlled study; premature; preservation; prospective; randomized placebo controlled trial; reproductive

PROJECT SUMMARY In the United States, patients with sickle cell anemia (SCA) now survive into adulthood, making reproductive concerns increasingly important for this population. Little is known about how SCA affects women’s reproductive capacity. The ovaries may be among the end-organs injured by the oxidative and hypoxic- ischemic injury of SCA. Hydroxyurea, a chemotherapeutic used to treat SCA starting as early as 9 months of age, may also affect fertility. Methodologically rigorous studies have not yet been performed to identify whether women with SCA have compromised fertility as a consequence of baseline SCA or as a consequence of treatments for SCA. This knowledge is especially important because fertility concerns are a barrier to SCA treatment, and because fertility evaluation and preservation strategies exist, but indications for their use in women with SCA are absent. This study proposes measuring anti-mullerian hormone, an established biomarker of ovarian reserve, in samples from the Multi-Center Study of Hydroxyurea, the randomized placebo-controlled trial of hydroxyurea in adults with SCA. Anti-mullerian hormone levels will be compared in hydroxyurea and placebo treated subjects and within the placebo-treated group, the association of clinical characteristics with anti-mullerian hormone levels will be analyzed. Samples from this well phenotyped cohort provide an opportunity to study how untreated SCA and hydroxyurea may affect a marker of ovarian reserve in women with SCA. Another placebo-controlled trial of hydroxyurea in adults with SCA will never be performed. Thus, this research will serve as a springboard for prospective research on fertility markers in females with SCA. 1

项目摘要 在美国，镰状细胞贫血（SCA）的患者现在生存到成年 担心对这个人群越来越重要。关于SCA如何影响女性的知识知之甚少 生殖能力。卵巢可能是因氧化和低氧造成的最终孔子之一 SCA缺血性损伤。羟基脲，一种用于治疗SCA的化学疗法，早在9个月开始 年龄，也可能影响生育能力。尚未进行方法论严格的研究，以确定是否是否 SCA的妇女由于基线SCA或由于 SCA治疗。这些知识尤其重要，因为生育问题是SCA的障碍 治疗，并且由于存在生育能力评估和保存策略，但有指示 SCA的妇女不存在。这项研究提出了测量抗毛刺激素的提议，这是一个已建立的 卵巢储备的生物标志物，在羟基脲多中心研究的样品中 SCA成人的羟基脲的安慰剂对照试验。将比较抗毛刺激素水平 羟基脲和安慰剂治疗的受试者以及安慰剂治疗组内的临床协会 将分析具有抗毛刺激素水平的特征。来自这个良好表型队列的样品 提供一个机会来研究未经处理的SCA和羟基脲如何影响卵巢储备的标志 患有SCA的女性。在患有SCA的成年人的羟基脲的另一项安慰剂对照试验将永远不会进行。 这项研究将成为对女性的生育标记的前瞻性研究的跳板 SCA。 1