AMH Levels in Healthy Females

(AMH Trial)

Overseen By Jacquelyn Searcy

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Erin Rowell

Disqualifiers: Premature ovarian failure, Endocrine disorders, Diabetes, Autoimmune disorders, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how blood levels of AMH, a hormone related to egg production, correspond to reproductive development in females. Researchers will collect blood samples through venipuncture from girls and young women already undergoing routine surgeries, such as hernia repairs or the removal of benign lumps. Those without conditions affecting their ovaries or hormone levels and undergoing these specific surgeries might be suitable for this study. The goal is to map typical AMH levels during different developmental stages. As an unphased study, this research allows participants to contribute to a deeper understanding of reproductive health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that blood sample collection is safe for participants?

Research has shown that taking a blood sample, also called venipuncture, is generally safe. Most people experience only minor issues, such as a small bruise or some soreness at the needle site. Some might feel slightly lightheaded during or after the procedure.

On rare occasions, more serious side effects, such as a skin infection or a larger bruise, can occur. However, these are uncommon, and most people do not experience major problems with blood collection.

Taking blood samples is a routine procedure used worldwide, with safety measures in place to reduce risks. If there are concerns, it is advisable to consult a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it offers a new way to understand female reproductive health. Unlike standard diagnostic methods that might focus on symptoms or hormone levels, this study examines blood AMH (Anti-Müllerian Hormone) levels to provide insights into reproductive development. This approach could lead to more precise assessments of fertility and reproductive lifespan, offering a more tailored understanding of a woman's reproductive health than current methods.

What evidence suggests that blood sample collection is effective for assessing AMH levels in females?

Research has shown that the Anti-Müllerian Hormone (AMH) in the blood closely relates to female reproductive development. AMH helps predict the number of eggs remaining in the ovaries, offering an indication of fertility potential. Studies have found that AMH levels change as girls grow: they start low at birth, increase during childhood, and peak in the late teen years. Measuring these levels provides important insights into the development of a young girl's reproductive system. This study will collect blood samples to better understand normal AMH levels in girls from birth to 18 years old, which could aid in understanding their growth and future fertility.

Who Is on the Research Team?

Erin Rowell, MD

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My physical development is between Tanner Stage I and V.

I am having a minor surgery, like hernia repair or gallbladder removal.

I am a female who has started menstruating.

Exclusion Criteria

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

Pregnant females

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Blood Sample Collection

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

3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Blood sample collection

Trial Overview 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.

How Is the Trial Designed?

Group I: Blood sample collection Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Erin Rowell

Lead Sponsor

Trials

4

Recruited

850+

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Trials

275

Recruited

5,182,000+

Published Research Related to This Trial

The study involving 26 participants demonstrated that anti-Müllerian hormone (AMH) levels are highly stable in serum samples during repeated freezing and thawing, making serum the preferred sample type for AMH analysis.

In contrast, AMH levels were less stable in plasma samples and showed a decrease in values when stored at 5-7 °C, highlighting the importance of proper sample handling conditions for accurate biomarker assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Stability of the Anti-Müllerian Hormone in Serum and Plasma Samples under Various Preanalytical Conditions. Vrzáková, R., Šimánek, V., Topolčan, O., et al.[2023]

In a study of 137 healthy women, age was found to significantly decrease AMH (Anti-Müllerian Hormone) levels, which are important for assessing ovarian reserve, indicating that as women age, their reproductive potential may decline.

Smoking did not show a significant impact on AMH levels, suggesting that while age is a critical factor in reproductive health, smoking may not adversely affect this specific hormone in women with normal reproductive histories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking and AMH levels in women with normal reproductive history. Dafopoulos, A., Dafopoulos, K., Georgoulias, P., et al.[2022]

In a study of 66,793 fresh autologous embryo transfer cycles, AMH levels below 1 ng/mL were found to be an independent predictor of increased miscarriage rates in non-PCOS patients, with an odds ratio of 1.2, indicating a significant risk.

In contrast, for patients with PCOS, higher AMH levels did not correlate with increased miscarriage rates, suggesting that elevated AMH may reflect follicle quantity rather than oocyte quality, which complicates its predictive value in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AMH predicts miscarriage in non-PCOS but not in PCOS related infertility ART cycles. Arkfeld, C., Han, E., Tal, R., et al.[2023]

A study of 250 Puerto Rican women at a fertility clinic found that Anti-Müllerian Hormone (AMH) levels significantly decline with age, with a 47.7% reduction by ages 35-39 and a 73.8% reduction by age 40 compared to women aged 25-29.

The findings highlight the importance of monitoring AMH levels as a potential indicator of fertility, as the data shows a clear trend of decreasing AMH levels with advancing age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Serum Anti-Mullerian Hormone Values for Puerto Rican Women Presenting to a Fertility Center. Agosto-Ventura, AJ., Hawayek, JA., Rivera-Cruz, G., et al.[2020]

In a study of 1,654 African-American women aged 23-34, the median antimüllerian hormone (AMH) level was found to be 3.18 ng/mL, with levels peaking at age 25, indicating a significant but nonlinear relationship between age and AMH.

Factors such as body mass index, hormonal contraception use, and thyroid conditions were found to be inversely associated with AMH levels, while a history of abnormal menstrual bleeding and longer menstrual cycles positively correlated with AMH, suggesting that various health factors can influence ovarian reserve.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel correlates between antimüllerian hormone and menstrual cycle characteristics in African-American women (23-35 years-old). Marsh, EE., Bernardi, LA., Steinberg, ML., et al.[2022]

The TAP II device demonstrated excellent concordance with standard venipuncture for measuring serum anti-Müllerian hormone (AMH) levels, achieving an R-squared value of 0.99, compared to 0.87 for the ADx card, indicating that TAP is a reliable alternative for at-home testing.

Patients reported significantly less pain and a more favorable experience using the TAP device compared to the ADx card, with a Net Promoter Score of +72 for TAP versus -48 for ADx, highlighting TAP's advantages in both efficacy and user comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of at-home serum anti-Müllerian hormone testing: a head-to-head comparison study. Silliman, E., Chung, EH., Fitzpatrick, E., et al.[2022]

In a study of adult males, serum levels of anti-Müllerian hormone (AMH) were found to be more closely related to body weight, lean mass, and body surface area than to measures of body fat like BMI, suggesting that these factors are better predictors of AMH levels.

The research indicates that hemodilution, or the dilution of AMH due to increased blood volume from larger body size, is a significant factor affecting AMH concentrations in adult males, highlighting the need for normalization in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AMH in Males: Effects of Body Size and Composition on Serum AMH Levels. Tandl, V., Haudum, C., Eberhard, K., et al.[2023]

The new Gen II assay for anti-Müllerian hormone (AMH) is stable and reliable in serum, but whole blood samples show a significant increase in AMH levels (31%) when stored at room temperature for 4 days, indicating potential inaccuracies in measurements if not properly stored.

Storing whole blood samples at 4°C significantly reduces the increase in AMH levels, and samples processed within 5 hours into serum tubes with gel separators maintain reliable stability for over 5 days, suggesting optimal handling practices for accurate AMH measurement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stability of AMH measurement in blood and avoidance of proteolytic changes. Fleming, R., Fairbairn, C., Blaney, C., et al.[2013]

The study compared anti-Müllerian hormone (AMH) levels using two different assays (rev-Gen II and Access) in 74 volunteers and found that while both methods were strongly correlated, rev-Gen II consistently produced higher AMH values than Access under fresh conditions.

Automated Access assay demonstrated better stability and reproducibility for AMH measurements across various storage conditions, particularly when serum was stored at -20 °C or 0 to 4 °C, while rev-Gen II showed significant decreases in AMH levels under similar conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement of serum anti-Müllerian hormone by revised Gen II or automated assay: Reproducibility under various blood/serum storage conditions. Lee, JY., Kim, CH., Choe, SA., et al.[2023]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK97517/

Diagnostic venepuncture: systematic review of adverse events A systematic review was carried out in order to identify studies reporting adverse events in adults undergoing simple venepuncture for diagnostic or screening ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK138496/

Best practice in phlebotomy and blood collection - NCBI - NIH Both patients and health workers can be exposed through phlebotomy to blood from other people, putting them at risk from bloodborne pathogens.

3. hmdhealthcare.com hmdhealthcare.com/blog/venipuncture-procedure-side-effects-and-aftercare/

Venipuncture – Procedure, Side Effects, and Aftercare Minor bruising and hematoma, rash and skin irritation, soreness, and lightheadedness. Serious side effects. Cellulitis or bacterial infection of the skin, ...

4. ascls.org ascls.org/wp-content/uploads/2012/11/Brochure_Venipuncture_2017.pdf

Blood Specimen Collection (Venipuncture) What should I watch for after the procedure? A common complication from venipuncture is bruising (hematoma). This occurs when blood leaks out of the blood ...

5. webmd.com webmd.com/a-to-z-guides/what-is-phlebotomy

What is Phlebotomy? History, Risks, and Side Effects You could get sick to your stomach if the sight of blood bothers you or if you're afraid of needles. Don't feel bad -- this is common. You might ...