ThalassemiaNCT00327639
Factors Promoting Increased Rate and Success of Pregnancy in the Thalassemia Population in Toronto
An observational study of Thalassemia and Fertility, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Treatment of patients with beta thalassemia in North America has altered dramatically during the past 40 years, with improvements in transfusion therapy and introduction of iron chelation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thalassemia, Fertility, Pregnancy
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2005to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Thalassemia, thalassemia intermedia or E-thalassemia patients in Toronto
- Subject has attempted conception
Who cannot join
- Subject has any other form of blood disease
- Subject has not attempted conception
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University Health Network, Toronto General Hospital
Toronto, Ontario, M5G 2C4
Valerie M Joseph, 416-340-4800 ext. 6507, Valerie.Joseph@uhn.on.ca
About this study
Treatment of patients with beta thalassemia in North America has altered dramatically during the past 40 years, with improvements in transfusion therapy and introduction of iron chelation therapy. Thalassemia patients now enjoy an increased life expectancy to the fifth and sixth decades of life, with fertility and childbearing becoming important issues. Data regarding this important topic remain limited, without clear data regarding iron control including serial assessment of hepatic iron concentration, the need for assistance in becoming pregnant, and use of iron chelating agents during pregnancy. As the life expectancy increases and overall health improves in thalassemia, clear data on fertility, pregnancy complications, and the effect of pregnancy on maternal health in thalassemia patients are necessary since these will have a direct impact on patient care, quality of life, and patient expectations.
- Conditions
- Thalassemia, Fertility, Pregnancy
- Medical subject headings
- Thalassemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study startJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThalassemiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Nancy F Olivieri, MD, Principal investigator, University Health Network, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327639
- Sponsor's protocol ID
- 00000
- Status last verified
- Jul 2005
- First submitted
- 17 May 2006
- Last updated
- 18 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Promoting Increased Rate and Success of Pregnancy in the Thalassemia Population in Toronto
- ClinicalTrials.gov ID
- NCT00327639
- Acronym / sponsor ID
- 00000
- Conditions
- Thalassemia, Fertility, Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jul 2005
- First posted
- 18 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment of patients with beta thalassemia in North America has altered dramatically during the past 40 years, with improvements in transfusion therapy and introduction of iron chelation therapy. Thalassemia patients now enjoy an increased life expectancy to the fifth and sixth decades of life, with fertility and childbearing becoming important issues. Data regarding this important topic remain limited, without clear data regarding iron control including serial assessment of hepatic iron concentration, the need for assistance in becoming pregnant, and use of iron chelating agents during pregnancy. As the life expectancy increases and overall health improves in thalassemia, clear data on fertility, pregnancy complications, and the effect of pregnancy on maternal health in thalassemia patients are necessary since these will have a direct impact on patient care, quality of life, and patient expectations.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Thalassemia, thalassemia intermedia or E-thalassemia patients in Toronto
- Subject has attempted conception
Key exclusion criteria (2 listed)
- Subject has any other form of blood disease
- Subject has not attempted conception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2006.
Related trials for Thalassemia
Active, not recruiting
Evaluation the Safety and Efficacy of KL003 Cell Injection in the Treatment of Transfusion-dependent β-thalassemia.
Transfusion-dependent Beta-Thalassemia
RecruitingObservational study
Growth and Development-related Outcomes in Children With Transfusion-dependent Beta-thalassemia After Gene Therapy
Transfusion-dependent Beta-Thalassemia, Gene Therapy
Not yet recruiting
Gene Therapy of Beta Thalassemia Using a Self-inactivating Lentiviral Vector
Beta-Thalassemia
RecruitingPhase 1/2
β-Thalassemia Treatment With KL003 Cell Injection
Transfusion-dependent Beta-Thalassemia
Active, not recruitingPhase 3
A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)
Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy F Olivieri, MD principal investigator
University Health Network, Toronto General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thalassemia and Fertility, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anthony Apostoli, B.Sc. (416-340-4800 ext. 6069, Anthony.Apostoli@uhn.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2006; AzTrials last refreshed its copy on 8 Nov 2026.