Levels of Selected Microelements in Premature Ovarian Insufficiency

Overview

Aim: To evaluate plasma/urine/hair Lead (Pb), Cadmium (Cd), Gadolinium (Gd), Arsenic (As), Mercury (Hg), Cobalt (Co), Vanadium (V), Titanium (Ti), Sulfur (S), Chromium (Cr), Silver (Ag), Molybdenum (Mo), Boron (B), Lithium (Li), and Nickel (Ni) 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 50 women with idiopathic premature ovarian insufficiency and 50 controls. The blood/urine/hair for analyses will be obtained at the early follicular phase of the menstrual cycle and plasma Lead (Pb), Cadmium (Cd), Gadolinium (Gd), Arsenic (As), Mercury (Hg), Cobalt (Co), Vanadium (V), Titanium (Ti), Sulfur (S), Chromium (Cr), Silver (Ag), Molybdenum (Mo), Boron (B), Lithium (Li), and Nickel (Ni) levels will be measured using inductively coupled plasma-mass spectrometry.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 30, 2021

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 January 2020 and June 2021. The authors will be recruited 50 subjects with idiopathic POI, and 50 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 authors 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 plasma concentration of Lead (Pb), Cadmium (Cd), Gadolinium (Gd), Arsenic (As), Mercury (Hg), Cobalt (Co), Vanadium (V), Titanium (Ti), Sulfur (S), Chromium (Cr), Silver (Ag), Molybdenum (Mo), Boron (B), Lithium (Li), and Nickel (Ni), 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. Urine and hair samples will be collected at the same time. The plasma and urine samples will be stored in aliquots at -80°C prior to the analyses of Lead (Pb), Cadmium (Cd), Gadolinium (Gd), Arsenic (As), Mercury (Hg), Cobalt (Co), Vanadium (V), Titanium (Ti), Sulfur (S), Chromium (Cr), Silver (Ag), Molybdenum (Mo), Boron (B), Lithium (Li), and Nickel (Ni). Hair samples will be stored in envelopes at room temperature. The plasma/urine/hair Lead (Pb), Cadmium (Cd), Gadolinium (Gd), Arsenic (As), Mercury (Hg), Cobalt (Co), Vanadium (V), Titanium (Ti), Sulfur (S), Chromium (Cr), Silver (Ag), Molybdenum (Mo), Boron (B), Lithium (Li), and Nickel (Ni) level will be measured using inductively coupled plasma-mass spectrometry. Then, this study will be determined plasma/urine/hair Lead (Pb), Cadmium (Cd), Gadolinium (Gd), Arsenic (As), Mercury (Hg), Cobalt (Co), Vanadium (V), Titanium (Ti), Sulfur (S), Chromium (Cr), Silver (Ag), Molybdenum (Mo), Boron (B), Lithium (Li), and Nickel (Ni) levels in women with POI (n=50) compared to those of volunteer healthy women (n=50). Then, these microelements levels will be compared in both group.

Interventions

  • Diagnostic Test: ultrasound assessment
    • Lead (Pb), Cadmium (Cd), Gadolinium (Gd), Arsenic (As), Mercury (Hg), Cobalt (Co), Vanadium (V), Titanium (Ti), Sulfur (S), Chromium (Cr), Silver (Ag), Molybdenum (Mo), Boron (B), Lithium (Li), and Nickel (Ni) measurements

Arms, Groups and Cohorts

  • Premature ovarian insufficiency (POI)
    • POI is a clinical syndrome defined by loss of ovarian activity before the age of 40 years. POI is characterized by menstrual disturbance (amenorrhea or oligomenorrhea) with raised gonadotropins and low estradiol.
  • Control group
    • The study population will consist of 50 women with POI as a study group and 50 patients with normal healthy women as a control group. 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.

Clinical Trial Outcome Measures

Primary Measures

  • Levels of selected microelements in POI
    • Time Frame: 1 week
    • The primary outcome in these analyses will compare Lead (Pb), Cadmium (Cd), Gadolinium (Gd), Arsenic (As), Mercury (Hg), Cobalt (Co), Vanadium (V), Titanium (Ti), Sulfur (S), Chromium (Cr), Silver (Ag), Molybdenum (Mo), Boron (B), Lithium (Li), and Nickel (Ni) levels in the idiopathic POI group and control group.

Participating in This Clinical Trial

Inclusion Criteria

  • women with idiopathic POI – Healthy women Exclusion Criteria:

1. women with any systemic condition (such as chronic hypertension, renal disease) 2. history of using any medication 3. drug user 4. history/presence of malignancy 5. history of Radiotherapy/chemotherapy 6. polycystic ovary syndrome 7. endometriosis 8. Patients whose chromosome analysis result is not normal 9. history of ovarian surgery 10. Ovarian cysts/mass 11. pregnancy 12. lactation 13. women who get their hair coloured

Gender Eligibility: Female

POI is a clinical syndrome defined by loss of ovarian activity before the age of 40 years. POI is characterized by menstrual disturbance (amenorrhea or oligomenorrhea) with raised gonadotropins and low estradiol. It is estimated to affect 1% of women under the age of 40, 0.1% under 30 and 0.01% under 20.

Minimum Age: 18 Years

Maximum Age: 39 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cengiz Gokcek Women’s and Children’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ali Ovayolu, Principal Investigator – Cengiz Gokcek Women’s and Children’s Hospital
  • Overall Contact(s)
    • ali ovayolu, 00905326404060, drovayolu@yahoo.com

Citations Reporting on Results

European Society for Human Reproduction and Embryology (ESHRE) Guideline Group on POI, Webber L, Davies M, Anderson R, Bartlett J, Braat D, Cartwright B, Cifkova R, de Muinck Keizer-Schrama S, Hogervorst E, Janse F, Liao L, Vlaisavljevic V, Zillikens C, Vermeulen N. ESHRE Guideline: management of women with premature ovarian insufficiency. Hum Reprod. 2016 May;31(5):926-37. doi: 10.1093/humrep/dew027. Epub 2016 Mar 22.

Pan W, Ye X, Zhu Z, Li C, Zhou J, Liu J. A case-control study of arsenic exposure with the risk of primary ovarian insufficiency in women. Environ Sci Pollut Res Int. 2020 Jul;27(20):25220-25229. doi: 10.1007/s11356-020-08806-0. Epub 2020 Apr 28.

Maclaran K, Horner E, Panay N. Premature ovarian failure: long-term sequelae. Menopause Int. 2010 Mar;16(1):38-41. doi: 10.1258/mi.2010.010014. Review.

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