Infertility Clinical Trial
Official title:
Iron Status in Women With Infertility and Controls - a Prospective Case-control Study
NCT number | NCT05034250 |
Other study ID # | 20210608 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2021 |
Est. completion date | May 1, 2024 |
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | May 1, 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | 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". |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna | Vifor Pharma, Inc. |
Austria,
Chavarro 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. — View Citation
Cheong 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. — View Citation
Clancy 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. — View Citation
Cook JD. Adaptation in iron metabolism. Am J Clin Nutr. 1990 Feb;51(2):301-8. doi: 10.1093/ajcn/51.2.301. — View Citation
Gao 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. — View Citation
Hallberg 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. — View Citation
Hou 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. — View Citation
Ikeda 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. — View Citation
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. — View Citation
Milman 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. — View Citation
Milman 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. — View Citation
Rushton 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. — View Citation
Sami 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. — View Citation
Shahidi NT. Androgens and erythropoiesis. N Engl J Med. 1973 Jul 12;289(2):72-80. doi: 10.1056/NEJM197307122890205. No abstract available. — View Citation
Yang 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. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum ferritin in µg/L | Evaluation of a complete iron status including serum ferritin in women with infertility, recurrent miscarriage and healthy controls | 6 months | |
Secondary | serum iron in µg/dL | Evaluation of a complete iron status including serum iron in women with infertility, recurrent miscarriage and healthy controls | 6 months | |
Secondary | transferrin in mg/dL | Evaluation of a complete iron status including transferrin in women with infertility, recurrent miscarriage and healthy controls | 6 months | |
Secondary | transferin-saturation in % | Evaluation of a complete iron status including transferin-saturation in women with infertility, recurrent miscarriage and healthy controls | 6 months | |
Secondary | C-reactive protein mg/dL | Evaluation of a complete iron status including C-reactive protein in women with infertility, recurrent miscarriage and healthy controls | 6 months |
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