Ovarian Reserve in Diabetes Mellitus

NCT ID: NCT03859856

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-25

Study Completion Date

2019-08-15

Brief Summary

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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

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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.

Conditions

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Type1 Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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women with Type 1 diabetes mellitus

Reproductive age women diagnosed with type 1 diabetes mellitus

hormone panel and ultrasonography

Intervention Type 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 without Type 1 diabetes mellitus

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

hormone panel and ultrasonography

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Berna Aslan Cetin

Md, ObGYN

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kanuni SSTRH

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2018.10.23

Identifier Type: -

Identifier Source: org_study_id

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