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，镰状细胞性贫血（SCA）患者现在可以存活到成年期， 对这个群体越来越重要。关于SCA如何影响女性的 生殖能力卵巢可能是受氧化和缺氧损伤的终末器官之一， SCA缺血性损伤。羟基脲，一种用于治疗SCA的化疗药物，早在9个月时就开始使用。 年龄也可能影响生育能力。方法上严格的研究尚未进行，以确定是否 患有SCA的女性由于基线SCA或以下原因而降低了生育力： SCA的治疗。这方面的知识尤其重要，因为生育问题是SCA的障碍 治疗，并且因为生育力评估和保存策略存在，但其用于 没有SCA的女性。这项研究提出了测量抗苗勒管激素，一个既定的 卵巢储备功能的生物标志物，在来自羟基脲多中心研究的样本中， 在SCA成人中进行的一项安慰剂对照试验。抗苗勒管激素水平将比较， 在接受羟基脲和安慰剂治疗的受试者中，以及在安慰剂治疗组中， 将分析抗苗勒管激素水平的特征。来自该良好表型分型队列的样品 提供了一个研究未治疗的SCA和羟基脲如何影响卵巢储备标志物的机会， SCA的女性另一项在SCA成人中进行的羟基脲安慰剂对照试验将永远不会进行。 因此，这项研究将作为一个跳板，对女性生育标志物的前瞻性研究， SCA。 1