Iron deficiency in fertility treatment

Oral and intravenous iron substitution for the treatment of iron deficiency symptoms in the context of fertility treatment - an exploratory pilot study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000201-84-AT

Enrollment

Registered

2020-01-30

Start date

2020-04-07

Completion date

Unknown

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infertility

Interventions

Trade Name: Ferinject Product Name: Ferinject Pharmaceutical Form: Solution for infusion INN or Proposed INN: Eisen(III)-Carboxymaltose CAS Number: 9007-72-1 Other descriptive name: FERRIC CARBOXYMAL

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients with iron deficiency (with and without anemia) defined by serum ferritin =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to compare hemoglobin, transferrin and ferritin concentrations, as well as TSAT four weeks after oral or intravenous iron substitution for the treatment of iron deficiency in patients undergoing fertility treatment.;Secondary Objective: In addition to the main aim of the study, the evaluation and correlation of additional patient efficiency data obtained in the context of fertility treatment will be evaluated. These data are routinely obtained and logged. These include: • patient age • Weight and height • Time to start treatment • Ovarian stimulation • ovulation induction oocyte retrieval (number of MII oocytes) • fertilization • Day of embryo transfer • Change in embryo morphokinetics (time-lapse data) • implantation rate • Pregnancy • Baby take home rate;Primary end point(s): hemoglobin transferrin ferritin TSAT;Timepoint(s) of evaluation of this end point: Between 2nd-5th day of the cycle hemoglobin, transferrin and ferritin values and TSAT are determined. If there is iron deficiency, the patients are treated with either Ferretab® (oral) or Ferinject® (intravenous). 4 weeks after the first treatment (administration of Ferinject® or Ferretab®), bhemoglobin, transferrin and ferritin values, as well as TSAT will be again determined.	—

Measure

Time frame

Main Objective: The aim of the study is to compare hemoglobin, transferrin and ferritin concentrations, as well as TSAT four weeks after oral or intravenous iron substitution for the treatment of iron deficiency in patients undergoing fertility treatment.;Secondary Objective: In addition to the main aim of the study, the evaluation and correlation of additional patient efficiency data obtained in the context of fertility treatment will be evaluated. These data are routinely obtained and logged. These include: • patient age • Weight and height • Time to start treatment • Ovarian stimulation • ovulation induction oocyte retrieval (number of MII oocytes) • fertilization • Day of embryo transfer • Change in embryo morphokinetics (time-lapse data) • implantation rate • Pregnancy • Baby take home rate;Primary end point(s): hemoglobin transferrin ferritin TSAT;Timepoint(s) of evaluation of this end point: Between 2nd-5th day of the cycle hemoglobin, transferrin and ferritin values and TSAT are determined. If there is iron deficiency, the patients are treated with either Ferretab® (oral) or Ferinject® (intravenous). 4 weeks after the first treatment (administration of Ferinject® or Ferretab®), bhemoglobin, transferrin and ferritin values, as well as TSAT will be again determined.

—

Secondary

Measure	Time frame
Secondary end point(s): • Ovarian stimulation • ovulation induction oocyte retrieval (number of MII oocytes) • fertilization • Day of embryo transfer • Change in embryo morphokinetics (time-lapse data) • implantation rate • Pregnancy • Baby take home rate ;Timepoint(s) of evaluation of this end point: All end points will be evaluated within one treatment cycle (1month). Baby take home rate will be evaluated after child birth (9months)	—

Measure

Time frame

Secondary end point(s): • Ovarian stimulation • ovulation induction oocyte retrieval (number of MII oocytes) • fertilization • Day of embryo transfer • Change in embryo morphokinetics (time-lapse data) • implantation rate • Pregnancy • Baby take home rate ;Timepoint(s) of evaluation of this end point: All end points will be evaluated within one treatment cycle (1month). Baby take home rate will be evaluated after child birth (9months)

—

Countries

Austria

Contacts

Public ContactDepartment Research and Development

Das Kinderwunsch Institut Schenk GmbH

gregor.weiss@kinderwunsch-institut.at

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 27, 2026