Investigating the role of iron status in female infertility and recurrent miscarriage
Iron Status in Women With Infertility and Controls - a Prospective Case-control Study
This study is trying to see if low iron levels in women who have trouble getting pregnant or have repeated miscarriages affects their fertility compared to healthy women.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT05034250 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between iron status and female fertility by evaluating iron levels in women experiencing infertility and those with recurrent miscarriages. A control group of healthy women without infertility will also be included for comparison. The study will involve detailed blood sampling to assess iron levels and their potential impact on reproductive health. The findings may provide insights into how iron deficiency affects the endometrium and overall fertility.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 to 40 who are experiencing primary or secondary infertility or have a history of recurrent miscarriages.
Not a fit: Patients with inflammatory bowel disease, cardiac insufficiency, chronic kidney disease, malignant diseases, or polycystic ovary syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of iron deficiency in women facing infertility and recurrent miscarriages.
How similar studies have performed: While the relationship between iron status and reproductive health has been suggested in previous studies, this specific approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Women with infertility Inclusion criteria: * 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. Exclusion criteria: * Inflammatoric bowel disease, cardiac insufficiency, chronic kidney disease, any malignant diseases. * Polycystic ovary syndrome. * There is no "informed consent". Women with recurrent miscarriage Inclusion criteria: * 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. Exclusion criteria: * Inflammatoric bowel disease, cardiac insufficiency, chronic kidney disease, any malignant diseases. * Polycystic ovary syndrome * There is no "informed consent". Healthy controls Inclusion criteria: * 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. Exclusion criteria: * Inflammatoric bowel disease, cardiac insufficiency, chronic kidney disease, any malignant diseases. * Polycystic ovary syndrome * There is no "informed consent".
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Johannes Ott, MD, PhD — Medical University of Vienna
- Study coordinator: Johannes Ott, MD, PhD
- Email: johannes.ott@meduniwien.ac.at
- Phone: +436504010485
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.