sFlt- 1, PIGF, and Niacin Levels in Women With Premature Ovarian Insufficiency
Condition: Premature Ovarian Insufficiency
MeSH terms: Premature Birth; Menopause, Premature; Primary Ovarian Insufficiency
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): ultrasound assessment
Intervention type(s): Other
Intervention description(s): soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin measurementswith a commercially available enzyme-linked immunosorbent assay (ELISA) kit.
Other intervention name(s): soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin measurements
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The investigators consecutively will be recruited 45 subjects with POI, and 45 healthy
        women will be selected for the control group.