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Status unknownNCT04767451POI&MICROsUpdated Aug 31, 2021

Levels of Selected Microelements in Premature Ovarian Insufficiency

An observational study in Premature Ovarian Failure, sponsored by Cengiz Gokcek Women's and Children's Hospital. Status unknown at 1 site in Turkey. Open to female participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-31.

Sponsored by Cengiz Gokcek Women's and Children's Hospital · Observational

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 39 Years
Sex
Female
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Study summary

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.

Read the 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.

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Conditions studied

03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's planned enrollment of 100 is below the median of 112 across 777 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Cengiz Gokcek Women's and Children's Hospital is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The investigators consecutively will be recruited 50 subjects with POI, and 50 healthy women will be selected for the control group.

Inclusion criteria

  • women with idiopathic POI
  • Healthy women

Exclusion criteria

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

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.

    Diagnostic Test: ultrasound assessment

  • 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.

    Diagnostic Test: ultrasound assessment

Interventions

  • Diagnostic testultrasound 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

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What researchers measure

Primary outcomes

  1. Levels of selected microelements in POI

    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 (µg/L,mean±SD) in the idiopathic POI group and control group.

    Time frame: 1 week

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Study locations

1 of 1 sites recruiting
  • Cengiz Gokcek Women's and Child's hospital
    Gaziantep, 27010, Turkey
    Recruiting
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References and documents

Publications

  • 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. PubMed 27008889 ↗
  • 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. PubMed 32347494 ↗
  • 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. No abstract available. PubMed 20424285 ↗

Study documents

  • Protocol and statistical analysis plan · Feb 16, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04767451
Lead sponsor
Cengiz Gokcek Women's and Children's Hospital
Responsible party
Ali Ovayolu (Principal Investigator, Cengiz Gokcek Women's and Children's Hospital) — Principal investigator
First posted
Feb 23, 2021
Start date
Feb 25, 2021
Primary completion
Sep 30, 2021 (estimated)
Completion
Oct 30, 2021 (estimated)
Last update
Aug 31, 2021

Study contacts

ali ovayolu
Contact
drovayolu@yahoo.com
00905326404060
ali ovayolu, M.D.
Contact
drovayolu@yahoo.com
00905326404060

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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