Iron deficiency in fertility treatment

Phase 1

• Conditions: infertility; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2020-000201-84-AT
• Lead Sponsor: Das Kinderwunsch Institut Schenk GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-30
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

• Patients with iron deficiency (with and without anemia) defined by serum ferritin <30ng / ml and / or transferrin saturation (TSAT) <20%
• Primarily and secondarily sterile patients
• Patients with fertility treatment
• Age 18-40 at the time of enrollment
• Signed informed consent
• BMI between 19 and 29.9
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patients with severe acute or chronic inflammation
• obesity
• hirsutism
• Mental inability, unwillingness or language barrier that prevents or makes it difficult to understand the declaration of consent or the necessary cooperation
• Current iron substitution
• Simultaneous use of other dietary supplements that contain iron
• Allergies to iron supplements
• pregnancy
• Patients taking proton inhibitors
Anemia not caused by iron deficiency e.g. (microcytic anemia)
• Evidence of iron overload or iron disruption

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified