HealthyAMHNCT04537390
Anti-mullerian Hormone Levels in Healthy Females
A study testing Blood sample collection in people with Healthy, run by Erin Rowell at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Blood sample collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2016to 1 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Central venous catheter placement
- Supprelin insertion/removal
- Breast mass excision
- Gastrostomy tube insertion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Jacquelyn Searcy, 3122274758, FertilityPreservationMB@luriechildrens.org
Erin Rowell, MD
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Blood sample collection
- Keywords
- AMH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionDiagnostic test
Blood samples are collected for diagnostically assessing how the blood AMH levels correspond to a female's reproductive development
| Study group | Role | What they receive |
|---|---|---|
| Blood sample collection | Other | Blood samples are collected for diagnostically assessing how the blood AMH levels correspond to a female's reproductive development Receives: Diagnostic Test: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start19 Jul 2016
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erin Rowell
- Sponsor type
- University, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago
- Responsible party
- Sponsor-investigator, Erin Rowell, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Erin Rowell, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537390
- Sponsor's protocol ID
- 2016-610
- Acronym
- AMH
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2020
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-mullerian Hormone Levels in Healthy Females
- ClinicalTrials.gov ID
- NCT04537390
- Acronym / sponsor ID
- AMH / 2016-610
- Conditions
- Healthy
- Keywords
- AMH
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Erin RowellUniversity, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago
- Study start
- 19 Jul 2016 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood sample collection | Other | Diagnostic Test: Blood sample collectionBlood samples are collected for diagnostically assessing how the blood AMH levels correspond to a female's reproductive development |
Who may qualify
- Ages
- Up to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Pre- and post-pubertal females
- Ages 0-18 years old
- Tanner Stage I- V
- Undergoing routine outpatient surgical procedure
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collectionBlood samples are collected for diagnostically assessing how the blood AMH levels correspond to a female's reproductive development | Diagnostic test | Blood sample collection |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erin Rowell, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample collection in people with Healthy, run by Erin Rowell at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacquelyn Searcy (3122274758, FertilityPreservationMB@luriechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-mullerian Hormone Levels in Healthy Females (time frame: 3 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.