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临床试验/NCT04641624
NCT04641624已完成不适用

Soluble Fms-like Tyrosine Kinase-1, Proangiogenic Protein Placental Growth Factor, and Niacin Levels in Women With Premature Ovarian Insufficiency

Cengiz Gokcek Women's and Children's Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
sFlt- 1 levels

研究概览

简要总结

Aim: To evaluate serum soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin levels in women with premature ovarian insufficiency (POI) and to compare the results with those of healthy subjects.

Methods: This prospective study will be included 45 women with idiopathic premature ovarian insufficiency and 45 controls. The blood for analysis will be obtained at the early follicular phase of the menstrual cycle and serum soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin levels will be measured using a commercially available ELISA kit.

详细描述

This will be an observational prospective cohort study conducted at Obstetrics and Gynecology Department of Cengiz Gokcek Obstetrics and Children's Hospital between November 2020 and April 2021. The investigators will be recruited 45 subjects with idiopathic POI, and 45 healthy patients were selected for the control group. All patients will be given their oral and written informed consent before their inclusion in the study. The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University (Reference number: 2020/320). The study strictly will be adhered to the principles of the Declaration of Helsinki.

Women between the ages of 18-39 will be included. A volunteer group of healthy women who will be visited the gynecology clinic for routine examinations and women who will be admitted for pre-pregnancy tests will be invited randomly to this research as a control group. Healthy women, who will be returned during their early follicular phase of the menstrual cycle, will be recruited as the control group subjects. The exclusion criteria will be as follows: women with evidence for karyotypic, metabolic, toxic, or iatrogenic cause of the ovarian insufficiency and any women who use any medication for POI treatment. At enrollment, for both groups, the investigators will be collected data about age, height, weight, BMI, age of menarche, obstetrics history, history of smoking, regular exercise and family history of POI. At enrolment, all patients will be underwent vaginal ultrasonography for the assessment of antral follicle count (AFC) and venous blood sample from the antecubital veins for measuring serum concentration of soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin, Follicle-stimulating hormone (FSH), E2, anti-mullerian hormone (AMH) and complete blood count (CBC). In control subjects venous blood samples and AFC will be collected during the early follicular phase of the menstrual cycle. The serum samples will be stored in aliquots at -80°C prior to the analyses of sFlt- 1, PIGF, and niacin. The serum soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin level will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit. Then, this study will be determined maternal serum soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin levels in women with POI (n=45) compared to those of volunteer healthy women (n=45). Then, these three markers levels will be compared in both group.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women with POI
  • Healthy women

排除标准

  • women with any systemic condition (such as chronic hypertension, renal disease)
  • history of using any medication
  • history/presence of malignancy
  • history of Radiotherapy/chemotherapy
  • polycystic ovary syndrome
  • women who had any other acute/chronic infection or fever
  • Patients whose chromosome analysis result is not normal
  • history of ovarian surgery
  • Ovarian cysts/mass

结局指标

主要结局

sFlt- 1 levels

时间窗: 1 week

The primary outcome measure in this analysis will compare sFlt- 1 levels in the idiopathic POI group and control group.

PIGF levels

时间窗: 1 week

The primary outcome measure in this analysis will compare PIGF levels in the idiopathic POI group and control group.

niacin levels

时间窗: 1 week

The primary outcome measure in this analysis will compare niacin levels in the idiopathic POI group and control group.

次要结局

未报告次要终点

研究者

发起方
Cengiz Gokcek Women's and Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Ovayolu

Principal Investigator

Cengiz Gokcek Women's and Children's Hospital

研究点 (1)

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