Anti-mullerian Hormone Levels in Healthy Females

NCT ID: NCT04537390

Last Updated: 2024-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-19

Study Completion Date

2030-12-01

Brief Summary

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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

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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

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Blood sample collection

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

Group Type OTHER

Blood sample collection

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Blood sample collection

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role collaborator

Erin Rowell

OTHER

Sponsor Role lead

Responsible Party

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Erin Rowell

Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Erin Rowell, MD

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Locations

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Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jacquelyn Searcy

Role: CONTACT

3122274758

Facility Contacts

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Jacquelyn Searcy

Role: primary

3122274758

Erin Rowell, MD

Role: backup

Other Identifiers

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2016-610

Identifier Type: -

Identifier Source: org_study_id

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