Sickle Cell AnemiaSAFENCT07116772
Serial Assessment of Fertility Experiences
An observational study of Sickle Cell Anemia, run by Children's Hospital Medical Center, Cincinnati at 3 sites in 3 countries.
Trial summary
The SAFE study is a long-term research project that watches people with sickle cell anemia (SCA) over time. The main goal is to see how a medicine called hydroxyurea affects their growth, puberty, and ability to have children. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Sickle Cell Anemia
- How many people
- 250 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 10 Jul 2023to 31 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People with sickle cell anemia who are at least 8 years old and seen in Jamaica and Dominican Republic.
Who may be able to join
- Patients with documented sickle cell anemia (SCA).
- At least 8 years of age at the time of enrollment.
- Enrolled on the EXTEND or SACRED study.
- Provide informed consent.
- Able to take part in all parts of the study, including treatments, check-ups, and follow-up visits.
Who cannot join
- Currently taking part in another treatment study (not EXTEND or SACRED).
- Has received other treatments for sickle cell disease in the past 6 months.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Dominican Republic1 site, 1 recruiting
- Recruiting
Centro de Obstetricia y Ginecologia
Santo Domingo
Teresa Latham, PhD, 513-803-7922, Teresa.Latham@cchmc.org
Rafael Mena, PhD
Jamaica1 site, 1 recruiting
- Recruiting
Caribbean Institute for Health Research, University of West Indies
Kingston
Teresa Latham, PhD, 513-803-7922, Teresa.Latham@cchmc.org
Marvin Reid, MB, BS, PhD
Tanzania1 site, 1 recruiting
- Recruiting
Buganda Medical Centre
Mwanza
Emmanuela Ambrose MD, emmanuelaambrose@gmail.com
Teresa Latham, PhD, 1-513-803-7922, teresa.latham@cchmc.org
About this study
Official title: A Prospective Longitudinal Study of Growth, Development, Fertility and Reproductive Outcomes Among Adolescents and Young Adults With Sickle Cell Anemia With Hydroxyurea
The SAFE study is a long-term research project that watches people with sickle cell anemia (SCA) over time. The main goal is to see how a medicine called hydroxyurea affects their growth, puberty, and ability to have children. A second goal is to see how hydroxyurea affects pregnancy outcomes, by comparing people who take the medicine to those who don't.
Read the detailed description
Hydroxyurea is a medicine that helps people with sickle cell anemia (SCA), a serious blood disease. It works by increasing a special type of hemoglobin (called fetal hemoglobin) that helps prevent sickle cell problems.
This medicine is especially helpful in places where it's hard to get safe blood transfusions. Studies from around the world have shown that hydroxyurea is safe and can reduce serious health problems caused by SCA (like pain, strokes, and lung issues). It can also help people with SCA live longer, healthier lives.
However, the investigators still don't know everything about how hydroxyurea affects long-term growth, puberty, fertility, or pregnancy; especially in areas with fewer medical resources.
To learn more, researchers are planning a large international study. They will follow people with SCA over time to see how hydroxyurea affects their development, ability to have children, and pregnancy outcomes. Participants will visit the clinic every few months for check-ups, blood tests, and other health assessments. Girls who have started their periods will take pregnancy tests every six months, and boys may be asked to provide a semen sample if they agree. Everyone will also answer questions about their health and fertility regularly.
- Conditions
- Sickle Cell Anemia
- Keywords
- Hydroxyurea, Fertility, Sickle Cell Disease
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sickle Cell Anemia | Those with sickle cell anemia (SCA). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcomes
The number of people who experience serious health events like pregnancy, stroke, cancer, or death.
Measured: From enrollment up to 10 years after enrollment.
Secondary outcomes (12)
Female Reproductive Potential and Outcomes
Female fertility potential will be measured using serum anti-mullerian hormone (physiologic parameter)
Measured: From enrollment up to 10 years after enrollment.
Female Reproductive Potential and Outcomes
Female ability to conceive will be assessed using incidence of pregnancy (questionnaire)
Measured: From enrollment up to 10 years after enrollment.
Female Reproductive Potential and Outcomes
Outcomes of pregnancy will be categorized as either abortion or live birth (questionnaire)
Measured: From enrollment up to 10 years after enrollment.
Female Reproductive Potential and Outcomes
Mode of delivery will be categorized as vaginal or c-section (questionnaire)
Measured: From enrollment up to 10 years after enrollment.
Female Reproductive Potential and Outcomes
Prematurity of infant will be categorized as premature or full term (questionnaire)
Measured: From enrollment up to 10 years after enrollment.
Female Reproductive Potential and Outcomes
Weight of infant will be categorized as normal birth weight or low birth weight (questionnaire)
Measured: From enrollment up to 10 years after enrollment.
Male Reproductive Potential and Outcomes
Male fertility potential will be measured using sperm analysis (physiologic parameter)
Measured: From enrollment up to 10 years after enrollment.
Male Reproductive Potential and Outcomes
Male ability to conceive will be assessed using incidence of impregnated partner (questionnaire)
Measured: From enrollment up to 10 years after enrollment.
Male Reproductive Potential and Outcomes
Outcomes of pregnancy will be categorized as either abortion or live birth (questionnaire)
Measured: From enrollment up to 10 years after enrollment.
Male Reproductive Potential and Outcomes
Mode of delivery will be categorized as vaginal or c-section (questionnaire)
Measured: From enrollment up to 10 years after enrollment.
Male Reproductive Potential and Outcomes
Prematurity of infant will be categorized as premature or full term (questionnaire)
Measured: From enrollment up to 10 years after enrollment.
Male Reproductive Potential and Outcomes
Weight of infant will be categorized as normal birth weight or low birth weight (questionnaire)
Measured: From enrollment up to 10 years after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start10 Jul 2023
- Primary completion19 May 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell AnemiaStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- The University of The West Indies, Centro de Obstetricia y Ginecologia Recruiting Santo Domingo, Dominican Republic
- Responsible party
- Sponsor
- Investigators
- Russell E Ware, MD, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116772
- Sponsor's protocol ID
- SAFE
- Acronym
- SAFE
- Status last verified
- Aug 2025
- First submitted
- 23 Jul 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study data will be collected and managed using REDCap™ electronic data capture tools. REDCap™ is a secure, web-based application designed to support data capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources. The REDCap™ system is available for use through institutions participating in the REDCap™ consortium. Cincinnati Children's Hospital Medical Center serves as the home institution to allow the REDCap™ system for de-identified data collection in the SAFE study.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Longitudinal Study of Growth, Development, Fertility and Reproductive Outcomes Among Adolescents and Young Adults With Sickle Cell Anemia With Hydroxyurea
- ClinicalTrials.gov ID
- NCT07116772
- Acronym / sponsor ID
- SAFE / SAFE
- Conditions
- Sickle Cell Anemia
- Keywords
- Hydroxyurea, Fertility, Sickle Cell Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- The University of The West Indies, Centro de Obstetricia y Ginecologia Recruiting Santo Domingo, Dominican Republic
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 19 May 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 12 Aug 2025 (actual)
- 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.
The SAFE study is a long-term research project that watches people with sickle cell anemia (SCA) over time. The main goal is to see how a medicine called hydroxyurea affects their growth, puberty, and ability to have children. A second goal is to see how hydroxyurea affects pregnancy outcomes, by comparing people who take the medicine to those who don't.
Detailed description
Hydroxyurea is a medicine that helps people with sickle cell anemia (SCA), a serious blood disease. It works by increasing a special type of hemoglobin (called fetal hemoglobin) that helps prevent sickle cell problems.
This medicine is especially helpful in places where it's hard to get safe blood transfusions. Studies from around the world have shown that hydroxyurea is safe and can reduce serious health problems caused by SCA (like pain, strokes, and lung issues). It can also help people with SCA live longer, healthier lives.
However, the investigators still don't know everything about how hydroxyurea affects long-term growth, puberty, fertility, or pregnancy; especially in areas with fewer medical resources.
To learn more, researchers are planning a large international study. They will follow people with SCA over time to see how hydroxyurea affects their development, ability to have children, and pregnancy outcomes. Participants will visit the clinic every few months for check-ups, blood tests, and other health assessments. Girls who have started their periods will take pregnancy tests every six months, and boys may be asked to provide a semen sample if they agree. Everyone will also answer questions about their health and fertility regularly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sickle Cell Anemia | – | –Those with sickle cell anemia (SCA). |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People with sickle cell anemia who are at least 8 years old and seen in Jamaica and Dominican Republic.
Key inclusion criteria (5 listed)
- Patients with documented sickle cell anemia (SCA).
- At least 8 years of age at the time of enrollment.
- Enrolled on the EXTEND or SACRED study.
- Provide informed consent.
- Able to take part in all parts of the study, including treatments, check-ups, and follow-up visits.
Key exclusion criteria (2 listed)
- Currently taking part in another treatment study (not EXTEND or SACRED).
- Has received other treatments for sickle cell disease in the past 6 months.
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
Clinical Outcomes
Time frame: From enrollment up to 10 years after enrollment.
The number of people who experience serious health events like pregnancy, stroke, cancer, or death.
12 secondary outcomes
Female Reproductive Potential and Outcomes
Time frame: From enrollment up to 10 years after enrollment.
Female Reproductive Potential and Outcomes
Time frame: From enrollment up to 10 years after enrollment.
Female Reproductive Potential and Outcomes
Time frame: From enrollment up to 10 years after enrollment.
Female Reproductive Potential and Outcomes
Time frame: From enrollment up to 10 years after enrollment.
Female Reproductive Potential and Outcomes
Time frame: From enrollment up to 10 years after enrollment.
Female Reproductive Potential and Outcomes
Time frame: From enrollment up to 10 years after enrollment.
Male Reproductive Potential and Outcomes
Time frame: From enrollment up to 10 years after enrollment.
Male Reproductive Potential and Outcomes
Time frame: From enrollment up to 10 years after enrollment.
Male Reproductive Potential and Outcomes
Time frame: From enrollment up to 10 years after enrollment.
Male Reproductive Potential and Outcomes
Time frame: From enrollment up to 10 years after enrollment.
Male Reproductive Potential and Outcomes
Time frame: From enrollment up to 10 years after enrollment.
Male Reproductive Potential and Outcomes
Time frame: From enrollment up to 10 years after enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- SACRED ClinicalTrials.gov PostingLink provided by the sponsor.
- EXTEND ClinicalTrials.gov PostingLink provided by the sponsor.
- Individual participant dataSharing planned: No. Study data will be collected and managed using REDCap™ electronic data capture tools. REDCap™ is a secure, web-based application designed to support data capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources. The REDCap™ system is available for use through institutions participating in the REDCap™ consortium. Cincinnati Children's Hospital Medical Center serves as the home institution to allow the REDCap™ system for de-identified data collection in the SAFE study.
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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.
Russell E Ware, MD, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Anemia, run by Children's Hospital Medical Center, Cincinnati at 3 sites in 3 countries.
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 5 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: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Dominican Republic, Jamaica, Tanzania. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teresa Latham, DrPh (513-803-7822, Teresa.Latham@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Outcomes (time frame: From enrollment up to 10 years after enrollment.). It is what the study was designed to measure, not a finding.
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 4 Feb 2026.