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CompletedNCT04024449Updated Jul 18, 2019

Can Celiac Disease Affect Ovarian Function in Adolescent?

An observational study in Celiac Disease and Ovarian Failure, sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital. Completed at 1 site in Turkey. Open to female participants aged 13 Years to 20 Years. Per ClinicalTrials.gov, last updated 2019-07-18.

Sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
37
Ages
13 Years to 20 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Celiac Disease
  • Ovarian Failure

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In context

Celiac Disease

333 studies on the registry are indexed under Celiac Disease; 78 are open to participants now.

This study's enrollment of 37 is below the median of 160 across 126 observational studies indexed under Celiac Disease.

Browse Celiac Disease studies →

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital is the lead sponsor of 118 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
13 Years to 20 Years
Sexes eligible
Female
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.

Inclusion criteria

  • •Celiac disease and control group with 13 ≤ Age ≤20

    • At least one year after menarche

Exclusion criteria

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.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
37 participants (actual)
Target follow-up
28 Days
Patient registry
Yes

Groups and cohorts

  • 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

  • OtherGroup A

    ovarian function test in control group

    Also known as: Celiac disease

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What researchers measure

Primary outcomes

  1. Anti mullerian Hormone (AMH)

    Level of AMH

    Time frame: on Day 3 menstruation

  2. Follicle Situmulating Hormone (FSH)

    Level of FSH

    Time frame: on Day 3 menstruation

  3. Ovarian Volume

    Ovarian volume measurement via Ultrasound

    Time frame: on Day 3 menstruation

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Study locations

1 site
  • Cihan Comba
    Istanbul, 34000, Turkey
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References and documents

Publications

  • 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. PubMed 32594297 ↗

Individual participant data

Plan to share: Yes — If the data is wanted, we will share data at any time.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04024449
Lead sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Responsible party
Sponsor
First posted
Jul 18, 2019
Start date
Jan 1, 2017
Primary completion
Jan 1, 2018
Completion
May 31, 2018
Last update
Jul 18, 2019

Study contacts

Atakan Comba, M.D.
study chair · Hitit University Department of Pediatric Gastroenterology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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