Recurrent MiscarriageNCT05034250
Iron Status in Female Infertility and Recurrent Miscarriage
An observational study of Recurrent Miscarriage and Infertility, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Multiple studies suggest a link between the iron status and the development of the endometrium. Therefore, a sufficient iron supply seems to relevant for female fertility and reproduction. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Miscarriage, Infertility, Iron-deficiency
- What is being tested?
- Blood sample
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2021to 1 May 2024
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women will be invited to participate by medical professionals at the Department of Obstetrics and Gynecology of the Medical University of Vienna, Clinical Division of Gynecologic Endocrinology and Reproductive Medicine, using the above-mentioned criteria in the course of their admission to the outpatient clinics. Potential participants are informed about the procedure, clinical relevance and the balance of risk and benefits incurred through study participation. Patients willing to participate will express this through written affirmation (a "consent form"). Healthy controls will not receive compensation.
Who may be able to join
- The patient suffers from primary or secondary infertility, defined as the inability to conceive despite frequent unprotected sexual intercourse for at least 12 months.
- The patient has given her written informed consent after detailed information on the study by medical professionals at the Department of Obstetrics and Gynecology of the Medical University of Vienna.
- The patient is >18 and <40 years old.
- The patient suffers from recurrent miscarriage, defined as three or more consecutive miscarriages before the 20th gestation week with the same partner.
- The patient has given her written informed consent after detailed information on the study by medical professionals at the Department of Obstetrics and Gynecology of the Medical University of Vienna.
- The patient is >18 and <40 years old.
Show all 9Show fewer
- The woman does neither suffer from infertility/sterility nor from recurrent miscarriage and is also otherwise healthy with regular cycles.
- The patient has given her written informed consent after detailed information on the study by medical professionals at the Department of Obstetrics and Gynecology of the Medical University of Vienna.
- The patient is >18 and <40 years old.
Who cannot join
- Inflammatoric bowel disease, cardiac insufficiency, chronic kidney disease, any malignant diseases.
- Polycystic ovary syndrome.
- There is no "informed consent".
- Women with recurrent miscarriage
- Inflammatoric bowel disease, cardiac insufficiency, chronic kidney disease, any malignant diseases.
- Polycystic ovary syndrome
Show all 11Show fewer
- There is no "informed consent".
- Healthy controls
- Inflammatoric bowel disease, cardiac insufficiency, chronic kidney disease, any malignant diseases.
- Polycystic ovary syndrome
- There is no "informed consent".
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Johannes Ott, Assoc.Prof.Priv.-Doz.Dr, +43 1 40400-28130, johannes.ott@meduniwien.ac.at
Daniel Mayrhofer, Dr.med.univ., +43 1 40400-28130, daniel.mayrhofer@meduniwien.ac.at
About this study
Official title: Iron Status in Women With Infertility and Controls - a Prospective Case-control Study
Multiple studies suggest a link between the iron status and the development of the endometrium. Therefore, a sufficient iron supply seems to relevant for female fertility and reproduction.
To gain further insight on the effects of iron status on female fertility, a prospective study on infertile women und women with recurrent miscarriage will be conducted. In these, the iron status will be evaluated in detail. In addition, a control group of healthy women without infertility will be enrolled.
Read the detailed description
The high importance of sufficient iron supply for the human body is without doubt. Notably, it has also been suggested that iron was a central resource in female reproduction.
Women are more prone to iron deficiency than men. It has been stated frequently that blood loss during menstruation was the major cause of lower iron levels in women. On average, women lose about 16 mg of iron for the average menstrual period. This is in line with several studies which demonstrated that women who had menorrhagia were at a higher risk of anemia and iron deficiency anemia. However, the link between menstruation-caused blood loss and iron status is less clear. In previous studies, it was found that higher hemoglobin was associated with a thicker endometrium. An improved body condition, as measured by iron status, might allow women to grow a thicker endometrium despite the fact that a thicker endometrium was associated with greater blood loss.
In addition, reproductive hormones are also implicated in iron status and are also responsible for the sexual dimorphism in iron levels in humans. For example, androgens stimulate the formation of red blood cells and are responsible for their higher hemoglobin levels. The role of estrogens is less clear, since studies have been contradicting. However, studies on the relationship between contraceptive pills and iron status may have provided the biggest clue to the effects of estrogen on iron physiology. Hormonal contraceptive use seems to raise iron stores. Notably, recent evidence suggests that estrogen itself, which also includes the estrogen in contraceptive pills, helps increase absorption of iron.
It has been mentioned that the iron status could be linked with fertility. As part of a larger study on iron supplementation and hair loss, the circumstances of seven women who became pregnant during the supplement intervention has been investigated. Despite the small number of women, this study suggests an intriguing link between iron status and ability to conceive. In addition, a larger, 8-year prospective study of 18,555 premenopausal women in the United States found that women who consumed iron supplements had a significantly lower risk of infertility than women who did not consume iron supplements. Together with the above mentioned observation that women with an improved iron status were able to grow a bigger endometrium, it seems reasonable to assume an influence of iron status on female fertility. Hypothetically, this could lead either to infertility/sterility or to recurrent miscarriage. Notably, one recent small study demonstrated no difference in iron levels between women with recurrent miscarriage and controls. Notably, other parameters of the iron status were not assessed. However, epidemiologic data on iron status and female fertility are scarce. Thus, a prospective study on infertile women und women with recurrent miscarriage will be conducted. In these women, the iron status will be evaluated in detail. In addition, a control group of healthy women without infertility will be enrolled.
- Conditions
- Recurrent Miscarriage, Infertility, Iron-deficiency
- Being tested
- Blood sample
- Keywords
- Iron status, Recurrent Miscarriage, Infertility
- Medical subject headings
- Abortion, Habitual, Infertility, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleDiagnostic test
Blood samples were taken from a peripheral vein as part of clinical routine. Subsequently, the iron status is determined.
| Study group | Role | What they receive |
|---|---|---|
| Women with infertility | The patient suffers from primary or secondary infertility, defined as the inability to conceive despite frequent unprotected sexual intercourse for at least 12 months. Receives: Diagnostic Test: Blood sample | |
| Women with recurrent miscarriage | The patient suffers from recurrent miscarriage, defined as three or more consecutive miscarriages before the 20th gestation week with the same partner. Receives: Diagnostic Test: Blood sample | |
| Healthy controls | The woman does neither suffer from infertility/sterility nor from recurrent miscarriage and is also otherwise healthy with regular cycles. Receives: Diagnostic Test: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum ferritin in µg/L
Evaluation of a complete iron status including serum ferritin in women with infertility, recurrent miscarriage and healthy controls
Measured: 6 months
Secondary outcomes (4)
serum iron in µg/dL
Evaluation of a complete iron status including serum iron in women with infertility, recurrent miscarriage and healthy controls
Measured: 6 months
transferrin in mg/dL
Evaluation of a complete iron status including transferrin in women with infertility, recurrent miscarriage and healthy controls
Measured: 6 months
transferin-saturation in %
Evaluation of a complete iron status including transferin-saturation in women with infertility, recurrent miscarriage and healthy controls
Measured: 6 months
C-reactive protein mg/dL
Evaluation of a complete iron status including C-reactive protein in women with infertility, recurrent miscarriage and healthy controls
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Oct 2021
- Primary completion1 Mar 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Recurrent MiscarriageStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Pharma, Inc.
- Responsible party
- Principal investigator, Johannes Ott, Medical University of Vienna
- Investigators
- Johannes Ott, MD, PhD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034250
- Sponsor's protocol ID
- 20210608
- Status last verified
- Oct 2023
- First submitted
- 19 Jul 2021
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miller EM. The reproductive ecology of iron in women. Am J Phys Anthropol. 2016 Jan;159(Suppl 61):S172-95. doi: 10.1002/ajpa.22907.
PubMed 26808104Cook JD. Adaptation in iron metabolism. Am J Clin Nutr. 1990 Feb;51(2):301-8. doi: 10.1093/ajcn/51.2.301.
PubMed 2407101Hallberg L, Hogdahl AM, Nilsson L, Rybo G. Menstrual blood loss--a population study. Variation at different ages and attempts to define normality. Acta Obstet Gynecol Scand. 1966;45(3):320-51. doi: 10.3109/00016346609158455. No abstract available.
PubMed 5922481Gao J, Zeng S, Sun BL, Fan HM, Han LH. Menstrual blood loss and hematologic indices in healthy Chinese women. J Reprod Med. 1987 Nov;32(11):822-6.
PubMed 3430490Cheong RL, Kuizon MD, Tajaon RT. Menstrual blood loss and iron nutrition in Filipino women. Southeast Asian J Trop Med Public Health. 1991 Dec;22(4):595-604.
PubMed 1820649Clancy KB, Nenko I, Jasienska G. Menstruation does not cause anemia: endometrial thickness correlates positively with erythrocyte count and hemoglobin concentration in premenopausal women. Am J Hum Biol. 2006 Sep-Oct;18(5):710-3. doi: 10.1002/ajhb.20538.
PubMed 16917885Shahidi NT. Androgens and erythropoiesis. N Engl J Med. 1973 Jul 12;289(2):72-80. doi: 10.1056/NEJM197307122890205. No abstract available.
PubMed 4575719Yang Q, Jian J, Katz S, Abramson SB, Huang X. 17beta-Estradiol inhibits iron hormone hepcidin through an estrogen responsive element half-site. Endocrinology. 2012 Jul;153(7):3170-8. doi: 10.1210/en.2011-2045. Epub 2012 Apr 25.
PubMed 22535765Ikeda Y, Tajima S, Izawa-Ishizawa Y, Kihira Y, Ishizawa K, Tomita S, Tsuchiya K, Tamaki T. Estrogen regulates hepcidin expression via GPR30-BMP6-dependent signaling in hepatocytes. PLoS One. 2012;7(7):e40465. doi: 10.1371/journal.pone.0040465. Epub 2012 Jul 11.
PubMed 22792339Milman N, Kirchhoff M, Jorgensen T. Iron status markers, serum ferritin and hemoglobin in 1359 Danish women in relation to menstruation, hormonal contraception, parity, and postmenopausal hormone treatment. Ann Hematol. 1992 Aug;65(2):96-102. doi: 10.1007/BF01698138.
PubMed 1511065Milman N, Rosdahl N, Lyhne N, Jorgensen T, Graudal N. Iron status in Danish women aged 35-65 years. Relation to menstruation and method of contraception. Acta Obstet Gynecol Scand. 1993 Nov;72(8):601-5. doi: 10.3109/00016349309021150.
PubMed 8259744Rushton DH, Ramsay ID, Gilkes JJ, Norris MJ. Ferritin and fertility. Lancet. 1991 Jun 22;337(8756):1554. doi: 10.1016/0140-6736(91)93255-8. No abstract available.
PubMed 1675411Chavarro JE, Rich-Edwards JW, Rosner BA, Willett WC. Iron intake and risk of ovulatory infertility. Obstet Gynecol. 2006 Nov;108(5):1145-52. doi: 10.1097/01.AOG.0000238333.37423.ab.
PubMed 17077236Sami AS, Suat E, Alkis I, Karakus Y, Guler S. The role of trace element, mineral, vitamin and total antioxidant status in women with habitual abortion. J Matern Fetal Neonatal Med. 2021 Apr;34(7):1055-1062. doi: 10.1080/14767058.2019.1623872. Epub 2019 Jul 7.
PubMed 31282231Hou Y, Zhang S, Wang L, Li J, Qu G, He J, Rong H, Ji H, Liu S. Estrogen regulates iron homeostasis through governing hepatic hepcidin expression via an estrogen response element. Gene. 2012 Dec 15;511(2):398-403. doi: 10.1016/j.gene.2012.09.060. Epub 2012 Oct 3.
PubMed 23041085
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Status in Women With Infertility and Controls - a Prospective Case-control Study
- ClinicalTrials.gov ID
- NCT05034250
- Acronym / sponsor ID
- 20210608
- Conditions
- Recurrent Miscarriage, Infertility, Iron-deficiency
- Keywords
- Iron status, Recurrent Miscarriage, Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Vifor Pharma, Inc.
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 5 Sep 2021 (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.
Multiple studies suggest a link between the iron status and the development of the endometrium. Therefore, a sufficient iron supply seems to relevant for female fertility and reproduction.
To gain further insight on the effects of iron status on female fertility, a prospective study on infertile women und women with recurrent miscarriage will be conducted. In these, the iron status will be evaluated in detail. In addition, a control group of healthy women without infertility will be enrolled.
Detailed description
The high importance of sufficient iron supply for the human body is without doubt. Notably, it has also been suggested that iron was a central resource in female reproduction.
Women are more prone to iron deficiency than men. It has been stated frequently that blood loss during menstruation was the major cause of lower iron levels in women. On average, women lose about 16 mg of iron for the average menstrual period. This is in line with several studies which demonstrated that women who had menorrhagia were at a higher risk of anemia and iron deficiency anemia. However, the link between menstruation-caused blood loss and iron status is less clear. In previous studies, it was found that higher hemoglobin was associated with a thicker endometrium. An improved body condition, as measured by iron status, might allow women to grow a thicker endometrium despite the fact that a thicker endometrium was associated with greater blood loss.
In addition, reproductive hormones are also implicated in iron status and are also responsible for the sexual dimorphism in iron levels in humans. For example, androgens stimulate the formation of red blood cells and are responsible for their higher hemoglobin levels. The role of estrogens is less clear, since studies have been contradicting. However, studies on the relationship between contraceptive pills and iron status may have provided the biggest clue to the effects of estrogen on iron physiology. Hormonal contraceptive use seems to raise iron stores. Notably, recent evidence suggests that estrogen itself, which also includes the estrogen in contraceptive pills, helps increase absorption of iron.
It has been mentioned that the iron status could be linked with fertility. As part of a larger study on iron supplementation and hair loss, the circumstances of seven women who became pregnant during the supplement intervention has been investigated. Despite the small number of women, this study suggests an intriguing link between iron status and ability to conceive. In addition, a larger, 8-year prospective study of 18,555 premenopausal women in the United States found that women who consumed iron supplements had a significantly lower risk of infertility than women who did not consume iron supplements. Together with the above mentioned observation that women with an improved iron status were able to grow a bigger endometrium, it seems reasonable to assume an influence of iron status on female fertility. Hypothetically, this could lead either to infertility/sterility or to recurrent miscarriage. Notably, one recent small study demonstrated no difference in iron levels between women with recurrent miscarriage and controls. Notably, other parameters of the iron status were not assessed. However, epidemiologic data on iron status and female fertility are scarce. Thus, a prospective study on infertile women und women with recurrent miscarriage will be conducted. In these women, the iron status will be evaluated in detail. In addition, a control group of healthy women without infertility will be enrolled.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Women with infertility | – | Diagnostic Test: Blood sampleThe patient suffers from primary or secondary infertility, defined as the inability to conceive despite frequent unprotected sexual intercourse for at least 12 months. |
| Women with recurrent miscarriage | – | Diagnostic Test: Blood sampleThe patient suffers from recurrent miscarriage, defined as three or more consecutive miscarriages before the 20th gestation week with the same partner. |
| Healthy controls | – | Diagnostic Test: Blood sampleThe woman does neither suffer from infertility/sterility nor from recurrent miscarriage and is also otherwise healthy with regular cycles. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women will be invited to participate by medical professionals at the Department of Obstetrics and Gynecology of the Medical University of Vienna, Clinical Division of Gynecologic Endocrinology and Reproductive Medicine, using the above-mentioned criteria in the course of their admission to the outpatient clinics. Potential participants are informed about the procedure, clinical relevance and the balance of risk and benefits incurred through study participation. Patients willing to participate will express this through written affirmation (a "consent form"). Healthy controls will not receive compensation.
Key inclusion criteria (9 listed)
- The patient suffers from primary or secondary infertility, defined as the inability to conceive despite frequent unprotected sexual intercourse for at least 12 months.
- The patient has given her written informed consent after detailed information on the study by medical professionals at the Department of Obstetrics and Gynecology of the Medical University of Vienna.
- The patient is >18 and <40 years old.
- The patient suffers from recurrent miscarriage, defined as three or more consecutive miscarriages before the 20th gestation week with the same partner.
- The patient has given her written informed consent after detailed information on the study by medical professionals at the Department of Obstetrics and Gynecology of the Medical University of Vienna.
Key exclusion criteria (11 listed)
- Inflammatoric bowel disease, cardiac insufficiency, chronic kidney disease, any malignant diseases.
- Polycystic ovary syndrome.
- There is no "informed consent".
- Women with recurrent miscarriage
- Inflammatoric bowel disease, cardiac insufficiency, chronic kidney disease, any malignant diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleBlood samples were taken from a peripheral vein as part of clinical routine. Subsequently, the iron status is determined. | Diagnostic test | Healthy controls, Women with infertility, Women with recurrent miscarriage |
Primary outcome
Serum ferritin in µg/L
Time frame: 6 months
Evaluation of a complete iron status including serum ferritin in women with infertility, recurrent miscarriage and healthy controls
4 secondary outcomes
serum iron in µg/dL
Time frame: 6 months
transferrin in mg/dL
Time frame: 6 months
transferin-saturation in %
Time frame: 6 months
C-reactive protein mg/dL
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Background: PubMed 26808104Miller EM. The reproductive ecology of iron in women. Am J Phys Anthropol. 2016 Jan;159(Suppl 61):S172-95. doi: 10.1002/ajpa.22907.
- Background: PubMed 2407101Cook JD. Adaptation in iron metabolism. Am J Clin Nutr. 1990 Feb;51(2):301-8. doi: 10.1093/ajcn/51.2.301.
- Background: PubMed 5922481Hallberg L, Hogdahl AM, Nilsson L, Rybo G. Menstrual blood loss--a population study. Variation at different ages and attempts to define normality. Acta Obstet Gynecol Scand. 1966;45(3):320-51. doi: 10.3109/00016346609158455. No abstract available.
- Background: PubMed 3430490Gao J, Zeng S, Sun BL, Fan HM, Han LH. Menstrual blood loss and hematologic indices in healthy Chinese women. J Reprod Med. 1987 Nov;32(11):822-6.
- Background: PubMed 1820649Cheong RL, Kuizon MD, Tajaon RT. Menstrual blood loss and iron nutrition in Filipino women. Southeast Asian J Trop Med Public Health. 1991 Dec;22(4):595-604.
- Background: PubMed 16917885Clancy KB, Nenko I, Jasienska G. Menstruation does not cause anemia: endometrial thickness correlates positively with erythrocyte count and hemoglobin concentration in premenopausal women. Am J Hum Biol. 2006 Sep-Oct;18(5):710-3. doi: 10.1002/ajhb.20538.
- Background: PubMed 4575719Shahidi NT. Androgens and erythropoiesis. N Engl J Med. 1973 Jul 12;289(2):72-80. doi: 10.1056/NEJM197307122890205. No abstract available.
- Background: PubMed 22535765Yang Q, Jian J, Katz S, Abramson SB, Huang X. 17beta-Estradiol inhibits iron hormone hepcidin through an estrogen responsive element half-site. Endocrinology. 2012 Jul;153(7):3170-8. doi: 10.1210/en.2011-2045. Epub 2012 Apr 25.
- Background: PubMed 22792339Ikeda Y, Tajima S, Izawa-Ishizawa Y, Kihira Y, Ishizawa K, Tomita S, Tsuchiya K, Tamaki T. Estrogen regulates hepcidin expression via GPR30-BMP6-dependent signaling in hepatocytes. PLoS One. 2012;7(7):e40465. doi: 10.1371/journal.pone.0040465. Epub 2012 Jul 11.
- Background: PubMed 1511065Milman N, Kirchhoff M, Jorgensen T. Iron status markers, serum ferritin and hemoglobin in 1359 Danish women in relation to menstruation, hormonal contraception, parity, and postmenopausal hormone treatment. Ann Hematol. 1992 Aug;65(2):96-102. doi: 10.1007/BF01698138.
- Background: PubMed 8259744Milman N, Rosdahl N, Lyhne N, Jorgensen T, Graudal N. Iron status in Danish women aged 35-65 years. Relation to menstruation and method of contraception. Acta Obstet Gynecol Scand. 1993 Nov;72(8):601-5. doi: 10.3109/00016349309021150.
- Background: PubMed 1675411Rushton DH, Ramsay ID, Gilkes JJ, Norris MJ. Ferritin and fertility. Lancet. 1991 Jun 22;337(8756):1554. doi: 10.1016/0140-6736(91)93255-8. No abstract available.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Johannes Ott, MD, PhD principal investigator
Medical University of Vienna
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 Recurrent Miscarriage and Infertility, run by Medical University of Vienna at 1 site in Austria.
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 9 inclusion and 11 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 23 Oct 2023. 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 Austria. 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 Johannes Ott, MD, PhD (+436504010485, johannes.ott@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum ferritin in µg/L (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05034250, which also lists 15 linked publications.
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 23 Oct 2023.