Anti-mullerian Hormone Levels in Healthy Females (AMH)

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Diagnostic test: Blood sample collection

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacquelyn Searcy; Phone Number: 3122274758; Email: FertilityPreservationMB@luriechildrens.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Ann & Robert H Lurie Children's Hospital of Chicago
      • Contact: Jacquelyn Searcy; Phone Number: 3122274758; Email: FertilityPreservationMB@luriechildrens.org
      • Contact: Erin Rowell, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Blood sample collection; Blood samples are collected for diagnostically assessing how the blood AMH levels correspond to a female's reproductive development	Diagnostic test: Blood sample collection; Blood samples are collected for diagnostically assessing how the blood AMH levels correspond to a female's reproductive development

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-mullerian Hormone Levels in Healthy Females	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	3 Years

Collaborators and Investigators

• Sponsor: Erin Rowell
• Collaborators: Ann & Robert H Lurie Children's Hospital of Chicago
• Investigators: Principal Investigator: Erin Rowell, MD, Ann & Robert H Lurie Children's Hospital of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2016
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: August 28, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (Actual): September 3, 2020

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: AMH
• Other Study ID Numbers: 2016-610

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No