Reproductive Capacity and Iron Burden in Thalassemia
| Status: | Recruiting |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2013 |
| End Date: | December 2016 |
| Contact: | Sylvia T Singer, MD |
| Email: | TSinger@mail.cho.org |
| Phone: | 510-428-3169 |
Reproductive Capacity and Association to Iron Burden and Chelation Patterns in Thalassemia Major Patients
The improved long-term survival of thalassemia major (TM) patients has resulted in increased
focus on the ability to preserve fertility. While the association of iron toxicity with
vital organ dysfunction, heart and liver, has been extensively investigated, the correlation
of reproductive capacity and extent of iron overload is not well understood. Despite
remarkable progress in methodology for prediction of reproductive status and intervention
for preserving fertility, implementation in thalassemia is lacking.
The investigators hypothesize that iron toxicity to the anterior pituitary occurring in the
process of transfusional iron loading is directly associated with a decline in gonadal
function. The investigators expect pituitary MRI measurements of iron deposition as well as
markers of oxidative damage to correlate with the functional studies of pituitary-gonadal
axis performed in this study. This cross sectional study will examine the relation of
pituitary iron deposition and pituitary volume; serum iron and oxidative stress measures,
liver iron concentration (LIC), cardiac iron and chelation adequacy with pituitary and
gonadal reproductive hormone levels (and spermatogenesis in adult male patients), in order
to better define the association of iron burden and chelation patterns with fertility
potential, in thalassemia patients with iron overload. The study will assess whether the
current chelation treatment regimens, in particular during the pubertal developmental age,
are adequate for preserving fertility and could lead to improved chelation routines for
preventing the high prevalence of compromised fertility. In addition, by utilizing
state-of-the-art markers for fertility status, findings from this study may improve current
methods for screening for hypogonadism and reproductive potential and allow earlier
intervention.
The investigators propose to examine 26-30 patients, 12 years and older, with measures of
fertility potential, and correlate them to their current iron burden parameters and to the
cumulative iron effect as indicated by past iron overload patterns and chelation history.
focus on the ability to preserve fertility. While the association of iron toxicity with
vital organ dysfunction, heart and liver, has been extensively investigated, the correlation
of reproductive capacity and extent of iron overload is not well understood. Despite
remarkable progress in methodology for prediction of reproductive status and intervention
for preserving fertility, implementation in thalassemia is lacking.
The investigators hypothesize that iron toxicity to the anterior pituitary occurring in the
process of transfusional iron loading is directly associated with a decline in gonadal
function. The investigators expect pituitary MRI measurements of iron deposition as well as
markers of oxidative damage to correlate with the functional studies of pituitary-gonadal
axis performed in this study. This cross sectional study will examine the relation of
pituitary iron deposition and pituitary volume; serum iron and oxidative stress measures,
liver iron concentration (LIC), cardiac iron and chelation adequacy with pituitary and
gonadal reproductive hormone levels (and spermatogenesis in adult male patients), in order
to better define the association of iron burden and chelation patterns with fertility
potential, in thalassemia patients with iron overload. The study will assess whether the
current chelation treatment regimens, in particular during the pubertal developmental age,
are adequate for preserving fertility and could lead to improved chelation routines for
preventing the high prevalence of compromised fertility. In addition, by utilizing
state-of-the-art markers for fertility status, findings from this study may improve current
methods for screening for hypogonadism and reproductive potential and allow earlier
intervention.
The investigators propose to examine 26-30 patients, 12 years and older, with measures of
fertility potential, and correlate them to their current iron burden parameters and to the
cumulative iron effect as indicated by past iron overload patterns and chelation history.
Inclusion Criteria:
- Transfusion-dependent* females and males with thalassemia (any genotype) who are 12
to 45 years of age.
- History of at least 5 years of chronic transfusion (defined as ≥ 8 transfusions/year)
(Age of initiation of transfusions does not matter)
- Any pubertal stage.
- Liver iron evaluated by SQUID, MRI or liver biopsy within 12 months prior to
enrollment in the study.
- Need to be able to stop hormonal therapy for 3 weeks (males) and one month (females)
prior to study enrollment.
Exclusion Criteria:
- Pregnant or lactating during study enrollment
- Unable to obtain liver iron concentration within 12 months prior or 6 months after
study entry.
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