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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01973075
Other study ID # 22547
Secondary ID
Status Completed
Phase N/A
First received October 20, 2013
Last updated August 9, 2017
Start date November 2013
Est. completion date April 2017

Study information

Verified date August 2017
Source Sisli Etfal Training & Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Premature Ovarian Insufficiency (POI), first described by Albright in 1942, is defined as an increase in Follicle Stimulating Hormone (FSH), an insufficiency of the ovarian function leading to an early menopause (<40 years of age).Today, only 35% of POI's etiology can be explained. Causes enlightening POI may be enumerated as follows, according to their frequency: genetic mutations, autoimmune defects and abnormalities detected on the X chromosome.The purpose of the study is to determine the frequency of the genetic abnormalities and polymorphisms described above in the POI Turkish population


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date April 2017
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- Clinical diagnosed premature ovarian failure patients

- 20-40 years old female patients

Exclusion Criteria:

- Surgical surgical menopause

- Female patients who can't meet the age range criteria

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Istanbul University Cerrahpasa Medical school Obstetrics department Istanbul

Sponsors (2)

Lead Sponsor Collaborator
BEGUM AYDOGAN Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Genetic etiology in Premature ovarian Insufficiency In the framework of our project, abnormalities on the X chromosome will be studied by karyotyping, follicle-stimulating hormone receptor (FSHR),nuclear receptor subfamily 5,group A,member 1 (NR5A1),Newborn ovary homeobox gene (NOBOX),Bone morphogenetic protein 15 (BMP15) genes will be analyzed by sequencing and finally repeat size analysis for FMR1 gene will be performed fragment analyses, on 75 POI and 25 healthy control population.Collected data will enable us to determine the frequency of the abnormalities and polymorphisms described above in the POI Turkish population. Patients free of those genetic variants will help us to identify new loci or genes implicated in POI. up to 1 year
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