NCT04537390

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy

Timeline
56mo left

Started Jul 2016

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Jul 2016Dec 2030

Study Start

First participant enrolled

July 19, 2016

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

November 18, 2024

Status Verified

November 1, 2024

Enrollment Period

14.4 years

First QC Date

August 28, 2020

Last Update Submit

November 14, 2024

Conditions

Healthy

Keywords

AMH

Outcome Measures

Primary Outcomes (1)

  • 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

    3 Years

Study Arms (1)

Blood sample collection

OTHER

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

Diagnostic Test: Blood sample collection

Interventions

Blood sample collectionDIAGNOSTIC_TEST

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

Blood sample collection

Eligibility Criteria

AgeUp to 18 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Study Officials

  • Erin Rowell, MD

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacquelyn Searcy

CONTACT

3122274758FertilityPreservationMB@luriechildrens.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 28, 2020

First Posted

September 3, 2020

Study Start

July 19, 2016

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

November 18, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)