Can Celiac Disease Affect Ovarian Function in Adolescent?

NCT04024449 | Completed

• 1 other identifier: 2018/166
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease; Ovarian Failure

Outcome Measures

Primary Outcomes (3)

• Anti mullerian Hormone (AMH)

  Level of AMH

  on Day 3 menstruation

• Follicle Situmulating Hormone (FSH)

  Level of FSH

  on Day 3 menstruation

• Ovarian Volume

  Ovarian volume measurement via Ultrasound

  on Day 3 menstruation

Study Arms (2)

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

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

Interventions

Group A OTHER

ovarian function test in control group

Also known as: Celiac disease

Celiac Disease; Control

Eligibility Criteria

• Age: 13 Years - 20 Years
• Sex: female
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population included 37 subjects in total. 20 people were in patients with celiac disease, 17 people were healthy adolescents.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Cihan Comba

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (1)

• Comba C, Comba A, Yilmaz H, Erdogan SV, Demir O. Celiac disease does not influence markers of ovarian reserve in adolescent girls. Arch Gynecol Obstet. 2020 Nov;302(5):1263-1269. doi: 10.1007/s00404-020-05666-4. Epub 2020 Jun 27.

  PMID: 32594297 DERIVED

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Atakan Comba, M.D.

  Hitit University Department of Pediatric Gastroenterology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 28 Days
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 18, 2019
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: May 31, 2018
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TU (1)