Anti-mullerian Hormone Levels in Healthy Females

Not Applicable

Recruiting

• Conditions: Healthy
• Interventions: Diagnostic Test: Blood sample collection

• Registration Number: NCT04537390
• Lead Sponsor: Erin Rowell

Brief Summary

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.

Study Timeline

• Study Start: 2016-07-19
• Study First Submitted: 2020-08-28
• Study First Submitted QC: 2020-08-28
• Study First Posted: 2020-09-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2030-12-01
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood sample collection	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

Name	Time	Method
Anti-mullerian Hormone Levels in Healthy Females	3 Years	The primary outcome measure is to get a better understanding of the normal AMH levels in children (girls aged 0-18 years) in order to better assess a girl's risk of not being able to have children if she is a cancer patient, and in offering her and her family options to increase the chances of having her own children

Trial Locations

Locations (1)

Ann & Robert H Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States