Can Celiac Disease Affect Ovarian Function in Adolescent?

Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04024449
Collaborator
(none)
37
1
16.9
2.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Group A

Detailed 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.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
37 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Colyak Hastaliginin Puberte ve Sonrasinda Over Fonksiyonlarina Etkisinin Arastirilmasi
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Jan 1, 2018
Actual Study Completion Date :
May 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Celiac Disease

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
ovarian function test in control group
Other Names:
  • Celiac disease
  • Control

    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
    Other Names:
  • Celiac disease
  • Outcome Measures

    Primary Outcome Measures

    1. Anti mullerian Hormone (AMH) [on Day 3 menstruation]

      Level of AMH

    2. Follicle Situmulating Hormone (FSH) [on Day 3 menstruation]

      Level of FSH

    3. Ovarian Volume [on Day 3 menstruation]

      Ovarian volume measurement via Ultrasound

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 20 Years
    Sexes Eligible for Study:
    Female
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cihan Comba Istanbul Turkey 34000

    Sponsors and Collaborators

    • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

    Investigators

    • Study Chair: Atakan Comba, M.D., Hitit University Department of Pediatric Gastroenterology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bakirkoy Dr. Sadi Konuk Research and Training Hospital
    ClinicalTrials.gov Identifier:
    NCT04024449
    Other Study ID Numbers:
    • 2018/166
    First Posted:
    Jul 18, 2019
    Last Update Posted:
    Jul 18, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 18, 2019