Levels of Selected Macroelements in Premature Ovarian Insufficiency

NCT04800705 | Unknown

• 1 other identifier: CengizGWCH23
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premature Ovarian Failure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Other: ultrasound assessment

Control group

The study population will be consisted of 70 women with POI as the study group and 70 patients with normal healthy women as the control group. A volunteer group of healthy women who will be visited the gynaecology 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.

Other: ultrasound assessment

Interventions

ultrasound assessment OTHER

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)

Also known as: elements concentrations measurements

Control group; Premature ovarian insufficiency (POI)

Eligibility Criteria

• Age: 18 Years - 39 Years
• Gender Eligibility Details: 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 gonadotrophins 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.
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The investigators consecutively will be recruited 70 subjects with POI, and 70 healthy women will be selected for the control group.

You may qualify if:

• women with idiopathic POI
• Healthy women

You may not qualify if:

• women with any systemic condition (such as chronic hypertension, renal disease)
• history of using any medication
• drug user
• history/presence of malignancy
• history of Radiotherapy/chemotherapy
• polycystic ovary syndrome
• endometriosis
• Patients whose chromosome analysis result is not normal
• history of ovarian surgery
• Ovarian cysts/mass
• pregnancy
• lactation

Sponsors & Collaborators

• Cengiz Gokcek Women's and Children's Hospital: lead
• The Scientific Research Project Fund of Yozgat Bozok University: collaborator

Study Sites (1)

Cengiz Gokcek Women's and Children's Hospital.

Gaziantep, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 27008889 RESULT

• 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.

  PMID: 20424285 RESULT

• 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.

  PMID: 29181820 RESULT

• 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.

  PMID: 31812447 RESULT

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

Ali Ovayolu, M.D.

CONTACT

00905326404060; drovayolu@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 16, 2021
• Study Start: March 15, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 30, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Locations

TU (1)