Skip to main content
OpenTrials
Completed

NCT Number: NCT04024449

Can Celiac Disease Affect Ovarian Function in Adolescent?

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

13 year–20 year

Sex eligibility

Female

Study type

Observational

Primary location

Cihan Comba

Istanbul, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • •Celiac disease and control group with 13 ≤ Age ≤20
  • At least one year after menarche

Exclusion criteria

  • delayed menarche, early puberty, delayed puberty, delayed development of secondary sexual characters due to another sexual disorder, obesity or malnutrition, Hyperandrogenism symptoms, and blood tests, Hyper or hypothyroidism, Hyperprolactinemia.

Treatment and study plan

Group A

Other

ovarian function test in control group

Other names: Celiac disease

Primary outcomes

  1. Anti mullerian Hormone (AMH)

    Time frame: on Day 3 menstruation

    Level of AMH

  2. Follicle Situmulating Hormone (FSH)

    Time frame: on Day 3 menstruation

    Level of FSH

  3. Ovarian Volume

    Time frame: on Day 3 menstruation

    Ovarian volume measurement via Ultrasound

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

Colyak Hastaliginin Puberte ve Sonrasinda Over Fonksiyonlarina Etkisinin Arastirilmasi

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 18, 2019
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.