Ovarian Reserve in Diabetes Mellitus

Completed

• Conditions: Type1 Diabetes Mellitus
• Interventions: Other: hormone panel and ultrasonography

• Registration Number: NCT03859856
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-11-25
• Status Verified: 2019-02
• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-01
• Primary Completion: 2019-08-15
• Study Completion: 2019-08-15
• Last Update Submitted: 2019-08-25
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Reproductive age group women: 18-40 years
• Women diagnosed with type 1 diabetes (case group)
• Women without type 1 diabetes (control group)

Read More

Exclusion Criteria

• Women with PCOS (polycystic ovary syndrome)
• history of ovarian surgery
• Body mass index (BMI) over 30

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
women with Type 1 diabetes mellitus	hormone panel and ultrasonography	Reproductive age women diagnosed with type 1 diabetes mellitus
women without Type 1 diabetes mellitus	hormone panel and ultrasonography	Reproductive age women diagnosed with type 1 diabetes mellitus to serve as control

Primary Outcome Measures

Name	Time	Method
antral follicle count	during procedure	antral follicles of ovaries will be counted with ultrasonography
E2, FSH, LH, AMH levels	during procedure	E2, FSH, LH, AMH levels of blood samples will be measured
ovarian volume	during procedure	both ovaries will be measured in three dimensions with ultrasonography

Trial Locations

Locations (1)

Kanuni SSTRH; 🇹🇷 Istanbul, Turkey