Recruiting

Observational Study

Sponsor:

Erin Rowell

Code:

NCT04537390

Conditions

Healthy

Eligibility Criteria

Sex: Female

Age: 0 - 18

Healthy Volunteers: Accepted

Interventions

Blood sample collection

Study Details

Brief 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.

Conditions

Healthy

Study ID

NCT04537390

Start date

Jul 19, 2016

Status verified date

Aug, 2026

Completion date

Dec 1, 2030

Anticipated

Primary completion date

Dec 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0 - 18

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Blood sample collection

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

Interventions

Blood sample collection

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

Primary outcome measure

  • Anti-mullerian Hormone Levels in Healthy Females [ Time Frame: 3 Years ]

Central Contacts and Locations

Locations

Ann & Robert H Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Erin Rowell, MD

More Information

Sponsor

Erin Rowell

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Keywords

  • AMH

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Erin Rowell on 2026-09-03.