An observational study in Celiac Disease and Ovarian Failure, sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital. Completed at 1 site in Turkey. Open to female participants aged 13 Years to 20 Years. Per ClinicalTrials.gov, last updated 2019-07-18.
Sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Observational
This case-control multicentre trial was performed from January 1, 2017, to May 31, 2018, in University of Health Sciences Bakirkoy Dr. Sadi Konuk Training and Research Hospital and Hitit University Hospital. Adolescents who were in compliance with the inclusion criteria were called by telephone for blood collection and ultrasound on the 3rd day of menstruation after approval from local ethical registration. On days 2-5 of the menstrual cycle, level of follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), prolactin (PRL), and AMH were measured from venous blood samples in both groups. Antral Follicle Counts (AFCs) and ovarian volumes were determined on the same day.
This case-control multicentre trial was performed from January 1, 2017, to May 31, 2018, in University of Health Sciences Bakirkoy Dr. Sadi Konuk Training and Research Hospital and Hitit University Hospital. This study was conducted with approval from the BTRH ethical board (number: 2018/166). This study covered 20 cases suffered from Celiac Disease and 18 were with regular menstrual period and healthy adolescent girls. Adolescents who were in compliance with the inclusion criteria were called by telephone for blood collection and ultrasound on the 3rd day of menstruation after approval from local ethical registration. Data on age, body mass index (BMI), levels of antitransglutaminase immune globulins A (IgA), positivity to antiendomysium IgA were recorded. On days 2-5 of the menstrual cycle, level of follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), prolactin (PRL), and AMH were measured from venous blood samples in both groups. The samples were centrifuged at 3,000 rpm for 10 minutes to aliquot the supernatants. Antral Follicle Counts (AFCs) and ovarian volumes were determined on the same day by the same ultrasound devices. The inclusion criteria included the following items;
IBM SPSS version 22.0 (IBM Corp., Armonk, NY, USA) was used for all data analyses. Descriptive statistics are presented as numbers and percentages (%) for qualitative variables and as mean ± standard deviation and median (range) for quantitative variables. Normality distribution of data was evaluated using Kolmogorov-Smirnov, and Shapiro-Wilk tests to guide statistical test choice.
333 studies on the registry are indexed under Celiac Disease; 78 are open to participants now.
This study's enrollment of 37 is below the median of 160 across 126 observational studies indexed under Celiac Disease.
Browse Celiac Disease studies →Bakirkoy Dr. Sadi Konuk Research and Training Hospital is the lead sponsor of 118 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population included 37 subjects in total. 20 people were in patients with celiac disease, 17 people were healthy adolescents.
•Celiac disease and control group with 13 ≤ Age ≤20
Exclusion Criteria:
Celiac disease with the following criteria; * 13 ≤ Age ≤20 * At least one year after menarche * Non-obesity or malnutrition, Non-Hyperandogenism symptoms, and blood tests, Non-Hyper or hypothyroidism, Non-Hyperprolactinemia.
Other: Group A
The adolescent with the following criteria; * 13 ≤ Age ≤20 * At least one year after menarche * Non-obesity or malnutrition, Non-Hyperandogenism symptoms, and blood tests, Non-Hyper or hypothyroidism, Non-Hyperprolactinemia. * Control group; with normal menstrual period, Non-chronic diseases
Other: Group A
ovarian function test in control group
Also known as: Celiac disease
Anti mullerian Hormone (AMH)
Level of AMH
Time frame: on Day 3 menstruation
Follicle Situmulating Hormone (FSH)
Level of FSH
Time frame: on Day 3 menstruation
Ovarian Volume
Ovarian volume measurement via Ultrasound
Time frame: on Day 3 menstruation
Plan to share: Yes — If the data is wanted, we will share data at any time.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Bakirkoy Dr. Sadi Konuk Research and Training Hospital