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NCT Number: NCT04537390

Anti-mullerian Hormone Levels in Healthy Females

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.

Recruiting

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Key information

Conditions

Age range

Up to 18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Erin Rowell, MD

CONTACT

Jacquelyn Searcy

CONTACT

[email protected]

3122274758

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample collection

Diagnostic Test

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

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jacquelyn Searcy

CONTACT

[email protected]

3122274758

Sponsors and collaborators

Lead sponsor

Erin Rowell

Other

Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago

Registry information

Acronym: AMH

Important dates

Study start
2016
Primary completion
2030
Study completion
2030
First posted
Sep 3, 2020
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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