Anti-mullerian Hormone Levels in Healthy Females
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sample collection.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: up to 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this study is to have a better understanding of the normal blood levels of AMH in females from 0-18 years of age and how the blood AMH levels correspond to a female's reproductive development.
Detailed description
Anti-mullerian hormone (AMH) is a chemical in the body that is found in the blood that can estimate the ability of a female to have her own children. It is widely used in adult female cancer patients to predict the onset of menopause and/or the inability to have children that can be associated with chemotherapy and/or radiation treatment. Normal blood levels of AMH are better understood in adults than in children and adolescents. The purpose of this study is to have a better understanding of the normal blood levels of AMH in females from 0-18 years of age and how the blood AMH levels correspond to a female's reproductive development. With a better understanding of normal AMH levels in children, we may be able to better assess a girl's risk of not being able to have children if she is a cancer patient, and may be able to offer her and her family options to increase the chances of having her own children.
Interventions
- Diagnostic test Blood sample collection
Blood samples are collected for diagnostically assessing how the blood AMH levels correspond to a female's reproductive development
Primary outcome measures
- Anti-mullerian Hormone Levels in Healthy Females [Time frame: 3 Years]
Eligibility criteria
Inclusion criteria
- Pre- and post-pubertal females
- Ages 0-18 years old
- Tanner Stage I- V
- Undergoing routine outpatient surgical procedure
- Hernia repair (inguinal, umbilical, epigastric)
- Excision of benign mass
- laparoscopic cholecystectomy
Exclusion criteria
- Previous diagnosis of an illness associated with premature ovarian failure (Turner's syndrome, Fragile X permutation carrier) or endocrine disorder associated with irregular menstrual cycles (Cushing's disease, poorly-controlled Thyroid disease, hyperprolactinemia, polycystic ovary syndrome, and congenital adrenal hyperplasia) or insulin-dependent diabetes mellitus or autoimmune disorders
- Previous diagnosis of any malignancy or any history of systemic/local chemotherapy, radiation therapy, or stem-cell transplant.
- Previous surgical excision of one ovary or both ovaries
- Pregnant females
- All inpatient surgical patients
- Undergoing non-routine outpatient surgical procedures
- Central venous catheter placement
- Supprelin insertion/removal
- Breast mass excision
- Gastrostomy tube insertion
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Ann & Robert H Lurie Children's Hospital of Chicago — Chicago
Identifiers
NCT: NCT04537390 · 2016-610