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出境医 / 临床实验 / Can Celiac Disease Affect Ovarian Function in Adolescent?

Can Celiac Disease Affect Ovarian Function in Adolescent?

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
Celiac Disease Ovarian Failure 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
Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 37 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 28 Days
Official Title: Colyak Hastaliginin Puberte ve Sonrasinda Over Fonksiyonlarina Etkisinin Arastirilmasi
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : May 31, 2018
Arms and Interventions
Group/Cohort 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 Name: 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 Name: Celiac disease

Outcome Measures
Primary Outcome Measures :
  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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   13 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   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.
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.
Contacts and Locations

Locations
Layout table for location information
Turkey
Cihan Comba
Istanbul, Turkey, 34000
Sponsors and Collaborators
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Investigators
Layout table for investigator information
Study Chair: Atakan Comba, M.D. Hitit University Department of Pediatric Gastroenterology
Tracking Information
First Submitted Date July 10, 2019
First Posted Date July 18, 2019
Last Update Posted Date July 18, 2019
Actual Study Start Date January 1, 2017
Actual Primary Completion Date January 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 17, 2019)
  • Anti mullerian Hormone (AMH) [ Time Frame: on Day 3 menstruation ]
    Level of AMH
  • Follicle Situmulating Hormone (FSH) [ Time Frame: on Day 3 menstruation ]
    Level of FSH
  • Ovarian Volume [ Time Frame: on Day 3 menstruation ]
    Ovarian volume measurement via Ultrasound
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Can Celiac Disease Affect Ovarian Function in Adolescent?
Official Title Colyak Hastaliginin Puberte ve Sonrasinda Over Fonksiyonlarina Etkisinin Arastirilmasi
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration 28 Days
Biospecimen Not Provided
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.
Condition
  • Celiac Disease
  • Ovarian Failure
Intervention Other: Group A
ovarian function test in control group
Other Name: Celiac disease
Study Groups/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.
    Intervention: 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
    Intervention: Other: Group A
Publications * Comba C, Comba A, Yılmaz 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 17, 2019)
37
Original Actual Enrollment Same as current
Actual Study Completion Date May 31, 2018
Actual Primary Completion Date January 1, 2018   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 13 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04024449
Other Study ID Numbers 2018/166
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: If the data is wanted, we will share data at any time.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Responsible Party Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Study Sponsor Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Collaborators Not Provided
Investigators
Study Chair: Atakan Comba, M.D. Hitit University Department of Pediatric Gastroenterology
PRS Account Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Verification Date July 2019

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