Celiac Disease Clinical Trial
Official title:
Colyak Hastaliginin Puberte ve Sonrasinda Over Fonksiyonlarina Etkisinin Arastirilmasi
NCT number | NCT04024449 |
Other study ID # | 2018/166 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2017 |
Est. completion date | May 31, 2018 |
Verified date | July 2019 |
Source | Bakirkoy Dr. Sadi Konuk Research and Training Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 37 |
Est. completion date | May 31, 2018 |
Est. primary completion date | January 1, 2018 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 13 Years to 20 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Cihan Comba | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Bakirkoy Dr. Sadi Konuk Research and Training Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anti mullerian Hormone (AMH) | Level of AMH | on Day 3 menstruation | |
Primary | Follicle Situmulating Hormone (FSH) | Level of FSH | on Day 3 menstruation | |
Primary | Ovarian Volume | Ovarian volume measurement via Ultrasound | on Day 3 menstruation |
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