- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04537390
Anti-mullerian Hormone Levels in Healthy Females (AMH)
September 1, 2026 updated by: Erin Rowell
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jacquelyn Searcy
- Phone Number: 3122274758
- Email: FertilityPreservationMB@luriechildrens.org
Study Locations
-
-
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
-
Principal Investigator:
- Erin Rowell, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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
|
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
Time Frame: 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
|
3 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Erin Rowell, MD, Ann & Robert H Lurie Children's Hospital of Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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 (Actual)
September 3, 2026
Last Update Submitted That Met QC Criteria
September 1, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2016-610
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.