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NCT02308904 · ClinicalTrials.gov registry record · NA
Reproductive Capacity and Iron Burden in Thalassemia
A NA study, sponsored by UCSF Benioff Children's Hospital Oakland.
- Completed
- Registry status
- NA
- Development phase
- 59
- Enrollment target
NCT02308904: Completed NA study, sponsored by UCSF Benioff Children's Hospital Oakland.
NCT02308904 is a NA study that has completed, run by UCSF Benioff Children's Hospital Oakland. The registered enrollment target is 59 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02308904, a NA study, has completed, sponsored by UCSF Benioff Children's Hospital Oakland.
- COMPLETED
- Registry status
- NA
- Development phase
- 59 participants
- Enrollment target
Study Summary
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
Interventions
- OTHER Blood Draw/Semen Exam
- OTHER Retrospective data/Chart Review/Relevant Clinical Results
- OTHER Pituitary MRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2013-06-01 |
| Est. Completion | 2020-09-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02308904
The ClinicalTrials.gov registry entry for NCT02308904 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UCSF Benioff Children's Hospital Oakland, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Blood Draw/Semen Exam is the first listed.
NCT02308904 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02308904 about?
NCT02308904 is a clinical study titled "Reproductive Capacity and Iron Burden in Thalassemia". 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 a...
What is the current status of trial NCT02308904?
This trial is currently completed. It is a NA study. The enrollment target is 59 participants. The study started on 2013-06-01. Estimated completion is 2020-09-01.
What interventions are being tested in trial NCT02308904?
The interventions under investigation include: Blood Draw/Semen Exam (OTHER), Retrospective data/Chart Review/Relevant Clinical Results (OTHER), Pituitary MRI (OTHER).
Who is sponsoring clinical trial NCT02308904?
This trial is sponsored by UCSF Benioff Children's Hospital Oakland, which has 52 total clinical trials registered on ClinicalTrials.gov.
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