Endocan Levels in Women With Premature Ovarian Insufficiency

NCT03924648 | Completed

• 1 other identifier: CengizGWCH
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To evaluate serum endocan levels in women with premature ovarian insufficiency (POI) and to compare the results with those of healthy subjects. Methods: This prospective study included 38 women with idiopathic POI and 39 controls. The blood for analysis was obtained at the early follicular phase of the menstrual cycle and serum endocan levels were measured using a commercially available ELISA kit. Follicle-stimulating hormone (FSH), estradiol, and anti-mullerian hormone (AMH) were measured at the same time. The continuous values were evaluated using Student's t-test, and categorical values were evaluated using the Chi-square test. P values \< .05 were accepted as significant.

Conditions

Premature Ovarian Failure

Keywords

Premature menopause; Premature ovarian insufficiency

Outcome Measures

Primary Outcomes (1)

• The primary endpoint in this analysis was to compare endocan levels in POI group and control group.

  The primary endpoint in this analysis was to compare endocan levels in POI group and control group.

  1 day

Study Arms (2)

premature ovarian insufficiency

Idiopatic premature ovarian insufficiency (POI), defined as loss of ovarian function and subsequent amenorrhea before the age of 40.

Other: Endocan levels

Control

The investigators compared patients with POI to a cohort of age matched healthy controls recruited among women who visited the gynecology clinic for routine examination or from hospital workers. All volunteers for the control group had regular menstrual cycles and no concomitant health problems.

Other: Endocan levels

Interventions

Endocan levels OTHER

Venous blood sample from the antecubital veins for measuring serum concentration of Endocan. The serum endocan level was measured using a commercially available ELISA kit, which is produced to detect human endocan levels with high sensitivity and specificity (Elabscience Biotechnology Inc., Houston, TX, USA). The endocan measurements were performed in accordance with company's protocol.

Control; premature ovarian insufficiency

Eligibility Criteria

• Age: 18 Years - 39 Years
• Gender Eligibility Details: Premature ovarian insufficiency (POI), defined as loss of ovarian function and subsequent amenorrhea before the age of 40
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The investigators consecutively recruited 38 subjects with idiopathic POI, and 39 healthy patients were selected for the control group. The investigators included patients with the diagnosis of idiopathic POI independently from the year of diagnosis. The investigators compared patients with POI to a cohort of age matched healthy controls recruited among women who visited the gynecology clinic for routine examination or from hospital workers. All participants for the control group had regular menstrual cycles and no concomitant health problems.

You may qualify if:

• idiopathic POI
• age-matched healthy controls.

You may not qualify if:

• Women with evidence for karyotypic, metabolic, toxic, or iatrogenic cause of the ovarian insufficiency
• Any women who use any medication for POI treatment,
• Women who had fever
• Women who had any Cardiovascular diseases

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)

Location

Related Publications (2)

• Maclaran K, Panay N. Current concepts in premature ovarian insufficiency. Womens Health (Lond). 2015 Mar;11(2):169-82. doi: 10.2217/whe.14.82.

  PMID: 25776291 BACKGROUND

• de Kat AC, Verschuren WM, Eijkemans MJ, Broekmans FJ, van der Schouw YT. Anti-Mullerian Hormone Trajectories Are Associated With Cardiovascular Disease in Women: Results From the Doetinchem Cohort Study. Circulation. 2017 Feb 7;135(6):556-565. doi: 10.1161/CIRCULATIONAHA.116.025968.

  PMID: 28153992 BACKGROUND

MeSH Terms

Conditions

Primary Ovarian Insufficiency; Menopause, Premature

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

Study Officials

• Ali Ovayolu, MD

  Cengiz Gokcek WCH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 23, 2019
• Study Start: July 1, 2018
• Primary Completion: December 30, 2018
• Study Completion: April 1, 2019
• Last Updated: April 23, 2019

Record last verified: 2019-04

Locations

TU (1)