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NCT03859856 Clinical Trial

Ovarian Reserve in Diabetes Mellitus

Type1 Diabetes Mellitus Clinical Trial

Official title:
Ovarian Reserve in Patients With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03859856
Other study ID # 2018.10.23
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 25, 2018
Est. completion date August 15, 2019

Study information
Verified date February 2019
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Type 1 diabetes mellitus is a common autoimmune disease. It affects women of all ages including reproductive years. Hyperglycemic condition in diabetes can cause organ damage. This study aims to measure serum hormones including FSH, LH, E2, AMH, ovarian volume and antral follicle count (indicators of ovarian reserve) in women with and without type 1 diabetes mellitus.

Description:

Type 1 diabetes mellitus is a common autoimmune disease. It affects women of all ages including reproductive years. It is showed that hyperglycemic state in diabetes results in organ damage like kidneys and eyes. Ovarian reserve is important for the reproductive period. The measurements of serum hormones including follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2) and anti-mullerian hormone (AMH) will give us an idea about the ovarian reserve. The investigators aim is to measure ovarian reserve parameters in patients diagnosed with type 1 diabetes mellitus and to compare them to healthy controls. Serum FSH, LH, E2 and AMH will be measured on the 3rd day of the cycle. Antral follicle count and ovarian volume measurement will be done with ultrasonography. Ovarian reserve markers will be compared between the groups.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date August 15, 2019
Est. primary completion date August 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Reproductive age group women: 18-40 years

- Women diagnosed with type 1 diabetes (case group)

- Women without type 1 diabetes (control group)

Exclusion Criteria:

- Women with PCOS (polycystic ovary syndrome)

- history of ovarian surgery

- Body mass index (BMI) over 30

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• hormone panel and ultrasonography
Blood sampling on the 3rd day of menstrual cycle for the measurement of serum FSH, LH, E2 and AMH hormone levels and ultrasonography for antral follicle count and ovarian volume measurement will be done.

Locations
Country Name City State
Turkey Kanuni SSTRH Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary E2, FSH, LH, AMH levels E2, FSH, LH, AMH levels of blood samples will be measured during procedure
Primary antral follicle count antral follicles of ovaries will be counted with ultrasonography during procedure
Primary ovarian volume both ovaries will be measured in three dimensions with ultrasonography during procedure
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