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Trial Title:
Anti-mullerian Hormone in Acute Lymphoblastic Leukemia
NCT ID:
NCT05793463
Condition:
Acute Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Conditions: Keywords:
Acute Lymphoblastic Leukemia
Fertility preservation
Anti-Mullerian hormone
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
Acute lymphoblastic leukemia (ALL) is the most common childhood malignancy, with current
survival rates exceeding 90%. As cure rates improve, increasing attention is focused on
survivor quality of life, including fertility. It is generally accepted that cancer
treatments in childhood may interfere with gonadal function, reducing the pool of
primordial follicles and consequently causing premature menopause in women.
Anti-Mullerian hormone (AMH) levels is a valuable quantitative indicator of ovarian
reserve, being directly related to the number of antral follicles. The evaluation of this
hormone makes it possible to identify women at risk of early menopause and to propose
them interventions for monitoring and preservation of oocytes, allowing girls to be able
to have children once they reach adulthood. The objective of this study is to determine
ovarian reserve in girls with ALL before and after treatment by means of the evaluation
of the AMH assay.
Criteria for eligibility:
Study pop:
Female less than 18 years of age with ALL
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Female less than 18 years of age
- Diagnosis of acute lymphoblastic leukemia
- enrollment within the first month after diagnosis
Exclusion Criteria:
- Previous treatments with cytostatics drugs
- ALL as a second malignancy
- Syndromic patient or primary hypogonadism
Gender:
Female
Gender based:
Yes
Minimum age:
1 Month
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
IRCCS Burlo Garofolo
Address:
City:
Trieste
Zip:
34137
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Nagua Giurici, MD
Phone:
+390403785342
Email:
nagua.giurici@burlo.trieste.it
Start date:
February 15, 2018
Completion date:
March 15, 2024
Lead sponsor:
Agency:
IRCCS Burlo Garofolo
Agency class:
Other
Source:
IRCCS Burlo Garofolo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05793463
