Ovarian Reserve in Diabetes Mellitus

NCT03859856 | Completed

• 1 other identifier: 2018.10.23
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• E2, FSH, LH, AMH levels

  E2, FSH, LH, AMH levels of blood samples will be measured

  during procedure

• antral follicle count

  antral follicles of ovaries will be counted with ultrasonography

  during procedure

• ovarian volume

  both ovaries will be measured in three dimensions with ultrasonography

  during procedure

Study Arms (2)

women with Type 1 diabetes mellitus

Reproductive age women diagnosed with type 1 diabetes mellitus

Other: hormone panel and ultrasonography

women without Type 1 diabetes mellitus

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

Other: hormone panel and ultrasonography

Interventions

hormone panel and ultrasonography OTHER

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.

women with Type 1 diabetes mellitus; women without Type 1 diabetes mellitus

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be reproductive age women diagnosed with type 1 diabetes mellitus. The control population will be aged and BMI matched women without type 1 diabetes mellitus.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni SSTRH

Istanbul, 34150, Turkey (Türkiye)

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md, ObGYN

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 1, 2019
• Study Start: November 25, 2018
• Primary Completion: August 15, 2019
• Study Completion: August 15, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-02

Locations

TU (1)