Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ovarian Reserve in Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03859856
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital

Tracking Information
First Submitted Date February 27, 2019
First Posted Date March 1, 2019
Last Update Posted Date March 1, 2019
Actual Study Start Date November 25, 2018
Estimated Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 28, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ovarian Reserve in Diabetes Mellitus
Official Title Ovarian Reserve in Patients With Type 1 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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Type1 Diabetes Mellitus
Intervention 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.
Study Groups/Cohorts
  • women with Type 1 diabetes mellitus
    Reproductive age women diagnosed with type 1 diabetes mellitus
    Intervention: Other: hormone panel and ultrasonography
  • women without Type 1 diabetes mellitus
    Reproductive age women diagnosed with type 1 diabetes mellitus to serve as control
    Intervention: Other: hormone panel and ultrasonography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 28, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 1, 2019
Estimated Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Berna Aslan Çetin 4141500 bernaaslan14@hotmail.com
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03859856
Other Study ID Numbers 2018.10.23
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital
Study Sponsor Kanuni Sultan Suleyman Training and Research Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Kanuni Sultan Suleyman Training and Research Hospital
Verification Date February 2019