Anti-mullerian Hormone Levels in Healthy Females (AMH)

Erin Rowell

Status: Enrolling

Conditions: Healthy

Treatments: Diagnostic Test: Blood sample collection

Study type: Interventional

Funder types: Other

Identifiers

NCT04537390

2016-610

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: Under 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Pre- and post-pubertal females

2. Ages 0-18 years old

3. Tanner Stage I- V

4. Undergoing routine outpatient surgical procedure

   1. Hernia repair (inguinal, umbilical, epigastric)
   2. Excision of benign mass
   3. laparoscopic cholecystectomy

Exclusion criteria

1. 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

2. Previous diagnosis of any malignancy or any history of systemic/local chemotherapy, radiation therapy, or stem-cell transplant.

3. Previous surgical excision of one ovary or both ovaries

4. Pregnant females

5. All inpatient surgical patients

6. Undergoing non-routine outpatient surgical procedures

   1. Central venous catheter placement
   2. Supprelin insertion/removal
   3. Breast mass excision
   4. Gastrostomy tube insertion

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Blood sample collection

Other group

Description:

Blood samples are collected for diagnostically assessing how the blood AMH levels correspond to a female's reproductive development

Treatment:

Diagnostic Test: Blood sample collection