Can Celiac Disease Affect Ovarian Function in Adolescent?

Celiac Disease Clinical Trial

Official title: Colyak Hastaliginin Puberte ve Sonrasinda Over Fonksiyonlarina Etkisinin Arastirilmasi

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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;

• 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 a normal menstrual period, Non-chronic diseases The study had exclusion criteria such as delayed menarche, early puberty, delayed puberty, delayed development of secondary sexual characters due to another sexual disorder.

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. ;

Related Conditions & MeSH terms

• Celiac Disease
• Ovarian Failure

• NCT number: NCT04024449
• Study type: Observational [Patient Registry]
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Status: Completed
• Start date: January 1, 2017
• Completion date: May 31, 2018