Ovarian Reserve in Diabetes Mellitus

Ovarian Reserve in Patients With Type 1 Diabetes Mellitus

Sponsors

Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Source 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.

Overall Status Completed
Start Date November 25, 2018
Completion Date August 15, 2019
Primary Completion Date August 15, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
E2, FSH, LH, AMH levels during procedure
antral follicle count during procedure
ovarian volume during procedure
Enrollment 100
Condition
Intervention

Intervention Type: Other

Intervention Name: hormone panel and ultrasonography

Description: 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.

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Healthy Volunteers: Accepts Healthy Volunteers

Location
Facility: Kanuni SSTRH
Location Countries

Turkey

Verification Date

February 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Kanuni Sultan Suleyman Training and Research Hospital

Investigator Full Name: Berna Aslan Cetin

Investigator Title: Md, ObGYN

Has Expanded Access No
Condition Browse
Arm Group

Label: women with Type 1 diabetes mellitus

Description: Reproductive age women diagnosed with type 1 diabetes mellitus

Label: women without Type 1 diabetes mellitus

Description: Reproductive age women diagnosed with type 1 diabetes mellitus to serve as control

Study Design Info

Observational Model: Case-Control

Time Perspective: Prospective

Source: ClinicalTrials.gov