Ovarian Reserve in Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT03859856 |
Recruitment Status :
Completed
First Posted : March 1, 2019
Last Update Posted : August 28, 2019
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Condition or disease | Intervention/treatment |
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Type1 Diabetes Mellitus | Other: hormone panel and ultrasonography |
Study Type : | Observational |
Actual Enrollment : | 100 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Ovarian Reserve in Patients With Type 1 Diabetes Mellitus |
Actual Study Start Date : | November 25, 2018 |
Actual Primary Completion Date : | August 15, 2019 |
Actual Study Completion Date : | August 15, 2019 |

Group/Cohort | Intervention/treatment |
---|---|
women with Type 1 diabetes mellitus
Reproductive age women diagnosed with type 1 diabetes mellitus
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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. |
women without Type 1 diabetes mellitus
Reproductive age women diagnosed with type 1 diabetes mellitus to serve as control
|
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. |
- E2, FSH, LH, AMH levels [ Time Frame: during procedure ]E2, FSH, LH, AMH levels of blood samples will be measured
- antral follicle count [ Time Frame: during procedure ]antral follicles of ovaries will be counted with ultrasonography
- ovarian volume [ Time Frame: during procedure ]both ovaries will be measured in three dimensions with ultrasonography

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859856
Turkey | |
Kanuni SSTRH | |
Istanbul, Turkey, 34150 |
Responsible Party: | Berna Aslan Cetin, Md, ObGYN, Kanuni Sultan Suleyman Training and Research Hospital |
ClinicalTrials.gov Identifier: | NCT03859856 |
Other Study ID Numbers: |
2018.10.23 |
First Posted: | March 1, 2019 Key Record Dates |
Last Update Posted: | August 28, 2019 |
Last Verified: | February 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Autoimmune Diseases Immune System Diseases Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |