Levels of Selected Microelements in Premature Ovarian Insufficiency

NCT04767451 | Unknown

• 1 other identifier: CengizGWCH22
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premature Ovarian Failure

Outcome Measures

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.

  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.

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

ultrasound assessment DIAGNOSTIC_TEST

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

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 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

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
• women who get their hair coloured

Sponsors & Collaborators

• Cengiz Gokcek Women's and Children's Hospital: lead

Study Sites (1)

Cengiz Gokcek Women's and Child's hospital

Gaziantep, 27010, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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

• 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.

  PMID: 32347494 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

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

CONTACT

00905326404060; drovayolu@yahoo.com

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: February 19, 2021
• First Posted: February 23, 2021
• Study Start: February 25, 2021
• Primary Completion: September 30, 2021
• Study Completion: October 30, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Locations

TU (1)