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Completed

NCT Number: NCT03859856

Ovarian Reserve in Diabetes Mellitus

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.

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Key information

Conditions

Type1 Diabetes Mellitus

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Kanuni SSTRH

Istanbul, 34150, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. E2, FSH, LH, AMH levels

    Time frame: during procedure

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

  2. antral follicle count

    Time frame: during procedure

    antral follicles of ovaries will be counted with ultrasonography

  3. ovarian volume

    Time frame: during procedure

    both ovaries will be measured in three dimensions with ultrasonography

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

Ovarian Reserve in Patients With Type 1 Diabetes Mellitus

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 1, 2019
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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