Can Celiac Disease Affect Ovarian Function in Adolescent?

NCT ID: NCT04024449

Last Updated: 2019-07-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2018-05-31

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.

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.

Conditions

Celiac Disease; Ovarian Failure

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Group A

Intervention Type: OTHER

ovarian function test in control group

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

Group A

Intervention Type: OTHER

ovarian function test in control group

Interventions

Group A

ovarian function test in control group

Intervention Type: OTHER

Other Intervention Names

Celiac disease

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Atakan Comba, M.D.

Role: STUDY_CHAIR

Hitit University Department of Pediatric Gastroenterology

Locations

Cihan Comba

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 32594297 (View on PubMed)

Other Identifiers

2018/166

Identifier Type: -

Identifier Source: org_study_id