Levels of Selected Macroelements in Premature Ovarian Insufficiency

Premature Ovarian Failure Clinical Trial

— POI&MACROs  

Official title:

Levels of Zinc (Zn), Copper (Cu), Calcium (Ca), Iron (Fe), Manganese (Mn), Selenium (Se), Strontium (Sr), Aluminium (Al), Antimonium (Sb), Phosphorus (P), Magnesium (Mg), Sodium (Na), Potassium (K), Barium (Ba) and Thallium (Tl) in Idiopathic Premature Ovarian Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04800705
• Other study ID #: CengizGWCH23
• Status: Recruiting
• Start date: March 15, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: August 2021
• Source: Cengiz Gokcek Women's and Children's Hospital
• Contact: Ali Ovayolu, M.D.
• Phone: 00905326404060
• Email: drovayolu[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aim: To evaluate plasma zinc (Zn), copper (Cu), calcium (Ca), iron (Fe), manganese (Mn), selenium (Se), strontium (Sr), aluminum (Al), antimonium (Sb), phosphorus (P), magnesium (Mg), sodium (Na), potassium (K), barium (Ba) and thallium (Tl) 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 70 women with idiopathic premature ovarian insufficiency and 70 controls. The blood/urine/hair for analyses will be obtained at the early follicular phase of the menstrual cycle and plasma zinc (Zn), copper (Cu), calcium (Ca), iron (Fe), manganese (Mn), selenium (Se), strontium (Sr), aluminum (Al), antimonium (Sb), phosphorus (P), magnesium (Mg), sodium (Na), potassium (K), barium (Ba) and thallium (Tl) levels will be measured using inductively coupled plasma-mass spectrometry.

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 September 2021. The authors will be recruited 70 subjects with idiopathic POI, and 70 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: 2021/343). 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 zinc (Zn), copper (Cu), calcium (Ca), iron (Fe), manganese (Mn), selenium (Se), strontium (Sr), aluminum (Al), antimonium (Sb), phosphorus (P), magnesium (Mg), sodium (Na), potassium (K), barium (Ba) and thallium (Tl), 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 zinc (Zn), copper (Cu), calcium (Ca), iron (Fe), manganese (Mn), selenium (Se), strontium (Sr), aluminum (Al), antimonium (Sb), phosphorus (P), magnesium (Mg), sodium (Na), potassium (K), barium (Ba) and thallium (Tl). Hair samples will be stored in envelopes at room temperature. The plasma/urine/hair zinc (Zn), copper (Cu), calcium (Ca), iron (Fe), manganese (Mn), selenium (Se), strontium (Sr), aluminum (Al), antimonium (Sb), phosphorus (P), magnesium (Mg), sodium (Na), potassium (K), barium (Ba) and thallium (Tl) level will be measured using inductively coupled plasma-mass spectrometry. Then, this study will be determined plasma/urine/hair zinc (Zn), copper (Cu), calcium (Ca), iron (Fe), manganese (Mn), selenium (Se), strontium (Sr), aluminum (Al), antimonium (Sb), phosphorus (P), magnesium (Mg), sodium (Na), potassium (K), barium (Ba) and thallium (Tl) levels in women with POI (n=70) compared to those of volunteer healthy women (n=70). Then, these macroelements levels will be compared in both groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 30, 2021
• Est. primary completion date: December 1, 2021
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Other:
• ultrasound assessment
Zinc (Zn), copper (Cu), calcium (Ca), iron (Fe), manganese (Mn), selenium (Se), strontium (Sr), aluminum (Al), antimonium (Sb), phosphorus (P), magnesium (Mg), sodium (Na), potassium (K), barium (Ba) and thallium (Tl) measurements (µg/L,mean±SD)

Locations

Country	Name	City	State
Turkey	Cengiz Gokcek Women's and Children's Hospital.	Gaziantep

Sponsors (2)

Lead Sponsor	Collaborator
Cengiz Gokcek Women's and Children's Hospital	The Scientific Research Project Fund of Yozgat Bozok University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Ekiz Yilmaz T, Tasdemir M, Kaya M, Arican N, Ahishali B. The effects of magnesium sulfate on cyclophosphamide-induced ovarian damage: Folliculogenesis. Acta Histochem. 2020 Feb;122(2):151470. doi: 10.1016/j.acthis.2019.151470. Epub 2019 Dec 4. — View Citation

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, V — View Citation

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. — View Citation

Verma P, K Sharma A, Shankar H, Sharma A, Rao DN. Role of Trace Elements, Oxidative Stress and Immune System: a Triad in Premature Ovarian Failure. Biol Trace Elem Res. 2018 Aug;184(2):325-333. doi: 10.1007/s12011-017-1197-6. Epub 2017 Nov 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	macroelements levels in the idiopathic POI group and control group	The primary outcome in these analyses will compare zinc (Zn), copper (Cu), calcium (Ca), iron (Fe), manganese (Mn), selenium (Se), strontium (Sr), aluminium (Al), antimonium (Sb), phosphorus (P), magnesium (Mg), sodium (Na), potassium (K), barium (Ba) and thallium (Tl) levels (µg/L,mean±SD) in the idiopathic POI group and control group.	1 week