Iron Status in Female Infertility and Recurrent Miscarriage

NCT05034250 | Unknown DMC

• 1 other identifier: 20210608
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Recurrent Miscarriage; Infertility; Iron-deficiency

Keywords

Iron status; Recurrent Miscarriage; Infertility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• serum iron in µg/dL

  6 months

• transferrin in mg/dL

  6 months

• transferin-saturation in %

  6 months

• C-reactive protein mg/dL

  6 months

Study Arms (3)

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.

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.

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.

Diagnostic Test: Blood sample

Interventions

Blood sample DIAGNOSTIC_TEST

Blood samples were taken from a peripheral vein as part of clinical routine. Subsequently, the iron status is determined.

Healthy controls; Women with infertility; Women with recurrent miscarriage

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Inflammatoric bowel disease, cardiac insufficiency, chronic kidney disease, any malignant diseases.
• Polycystic ovary syndrome.
• There is no "informed consent".
• 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.
• 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.
• Inflammatoric bowel disease, cardiac insufficiency, chronic kidney disease, any malignant diseases.
• Polycystic ovary syndrome
• There is no "informed consent".
• Healthy controls
• 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.
• Inflammatoric bowel disease, cardiac insufficiency, chronic kidney disease, any malignant diseases.

Sponsors & Collaborators

• Medical University of Vienna: lead
• Vifor Pharma, Inc.: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (15)

• 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.

  PMID: 26808104 BACKGROUND

• Cook JD. Adaptation in iron metabolism. Am J Clin Nutr. 1990 Feb;51(2):301-8. doi: 10.1093/ajcn/51.2.301.

  PMID: 2407101 BACKGROUND

• 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.

  PMID: 5922481 BACKGROUND

• 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.

  PMID: 3430490 BACKGROUND

• 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.

  PMID: 1820649 BACKGROUND

• 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.

  PMID: 16917885 BACKGROUND

• Shahidi NT. Androgens and erythropoiesis. N Engl J Med. 1973 Jul 12;289(2):72-80. doi: 10.1056/NEJM197307122890205. No abstract available.

  PMID: 4575719 BACKGROUND

• 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.

  PMID: 22535765 BACKGROUND

• 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.

  PMID: 22792339 BACKGROUND

• 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.

  PMID: 1511065 BACKGROUND

• 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.

  PMID: 8259744 BACKGROUND

• 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.

  PMID: 1675411 BACKGROUND

• 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.

  PMID: 17077236 BACKGROUND

• 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.

  PMID: 31282231 BACKGROUND

• 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.

  PMID: 23041085 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples taken as part of routine clinical practice: Total serum iron, serum ferritin, transferrin, transferrin saturation, C-reactive protein

MeSH Terms

Conditions

Abortion, Habitual; Infertility; Anemia, Iron-Deficiency

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Johannes Ott, MD, PhD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannes Ott, MD, PhD

CONTACT

+436504010485; johannes.ott@meduniwien.ac.at

Daniel Mayrhofer, MD

CONTACT

+436765612112; daniel.mayrhofer@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Consultant Physician

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: September 5, 2021
• Study Start: October 1, 2021
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)