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AMH Levels in Healthy Females (AMH Trial)

N/A

Recruiting

Led By Erin Rowell, MD

Research Sponsored by Erin Rowell

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 0-18 years old

Tanner Stage I- V

Must not have

Undergoing non-routine outpatient surgical procedures: Central venous catheter placement, Supprelin insertion/removal, Breast mass excision, Gastrostomy tube insertion

Previous diagnosis of any malignancy or any history of systemic/local chemotherapy, radiation therapy, or stem-cell transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to learn more about the typical levels of AMH in the blood of females aged 0-18 years and how these levels relate to their reproductive development."

Who is the study for?

This trial is for healthy pre- and post-pubertal females aged 0-18, at any stage of development (Tanner Stage I-V), who are already scheduled for routine outpatient surgeries like hernia repairs or benign mass excisions.

What is being tested?

The study involves collecting blood samples from participants to measure levels of Anti-Mullerian Hormone (AMH) and understand how AMH corresponds with reproductive development in girls and young women.

What are the potential side effects?

Since the intervention only includes drawing blood, side effects may be minimal such as temporary discomfort, bruising at the needle site, dizziness, or fainting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or younger.

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My physical development is between Tanner Stage I and V.

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I am a female who has started menstruating.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am scheduled for a specific outpatient surgery like a catheter placement or breast mass removal.

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I have had cancer before and received treatment like chemotherapy, radiation, or a stem-cell transplant.

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I have had surgery to remove one or both of my ovaries.

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I am a patient who has been admitted for surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anti-mullerian Hormone Levels in Healthy Females

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Blood sample collectionExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blood sample collection

2014

Completed Phase 4

~16190

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ann & Robert H Lurie Children's Hospital of ChicagoOTHER

273 Previous Clinical Trials

5,183,451 Total Patients Enrolled

Erin RowellLead Sponsor

3 Previous Clinical Trials

750 Total Patients Enrolled

Erin Rowell, MD5.01 ReviewsPrincipal Investigator - Ann & Robert H Lurie Children's Hospital of Chicago

Ann & Robert H Lurie Children's Hospital of Chicago

4 Previous Clinical Trials

850 Total Patients Enrolled

5Patient Review

Dr Rowell's bedside manner is excellent. My daughter was very nervous about her surgery, but Dr Rowell was very kind and patient with her, both before and after the surgery. We are very grateful.