Condition or disease | Intervention/treatment |
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Celiac Disease Ovarian Failure | Other: Group A |
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;
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] |
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 |
Group/Cohort | Intervention/treatment |
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Celiac Disease
Celiac disease with the following criteria;
|
Other: Group A
ovarian function test in control group
Other Name: Celiac disease
|
Control
The adolescent with the following criteria;
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Other: Group A
ovarian function test in control group
Other Name: Celiac disease
|
Ages Eligible for Study: | 13 Years to 20 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
•Celiac disease and control group with 13 ≤ Age ≤20
Exclusion Criteria:
Turkey | |
Cihan Comba | |
Istanbul, Turkey, 34000 |
Study Chair: | Atakan Comba, M.D. | Hitit University Department of Pediatric Gastroenterology |
Tracking Information | |||||||||||||||
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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 |
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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;
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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Study Type | Observational [Patient Registry] | ||||||||||||||
Study Design | Observational Model: Case-Control Time Perspective: Cross-Sectional |
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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 |
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Intervention | Other: Group A
ovarian function test in control group
Other Name: Celiac disease
|
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Study Groups/Cohorts |
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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. |
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Recruitment Information | |||||||||||||||
Recruitment Status | Completed | ||||||||||||||
Actual Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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IPD Sharing Statement |
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Responsible Party | Bakirkoy Dr. Sadi Konuk Research and Training Hospital | ||||||||||||||
Study Sponsor | Bakirkoy Dr. Sadi Konuk Research and Training Hospital | ||||||||||||||
Collaborators | Not Provided | ||||||||||||||
Investigators |
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PRS Account | Bakirkoy Dr. Sadi Konuk Research and Training Hospital | ||||||||||||||
Verification Date | July 2019 |