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Ovarian Reserve in Diabetes Mellitus

Ovarian Reserve in Patients With Type 1 Diabetes Mellitus

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03859856
Enrollment
100
Registered
2019-03-01
Start date
2018-11-25
Completion date
2019-08-15
Last updated
2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type1 Diabetes Mellitus

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.

Interventions

OTHERhormone 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.

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
E2, FSH, LH, AMH levelsduring procedureE2, FSH, LH, AMH levels of blood samples will be measured
antral follicle countduring procedureantral follicles of ovaries will be counted with ultrasonography
ovarian volumeduring procedureboth ovaries will be measured in three dimensions with ultrasonography

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026