NCT04510870

Iron Deficiency as an Ignored Cause of Infertility

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Dextra Fertility Clinic · Academic / Other
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Not accepted

Summary

Iron deficiency may play a critical role in human infertility, oocyte quality and may even play a role in endometrial receptivity. By correcting iron deficiency, low ferritin values, in infertile women with intravenous iron supplementation, embryo quality and pregnancy rates may improve. The main objective is to evaluate the effect of intravenous iron supplementation on embryo quality (number of good quality blastocysts). Randomized, double blind, parallel group, cross-over study of ferric carboxymaltose compared to placebo (NaCl infusion).

Conditions

• Iron Deficiency
• Infertility

Interventions

Type	Name	Description
DRUG	Ferric Carboxymaltose Injection	Infusion prior the start of IVF/ICSI cycle. Dosing according to the summary of product characteristics (SmPC) chart. Placebo infusion before frozen embryo transfer if needed.
DRUG	NaCl infusion	Placebo infusion prior the start of IVF/ICSI cycle. Ferric Carboxymaltose infusion before frozen embryo transfer if needed. Dosing according to the summary of product characteristics (SmPC) chart.

Timeline

• Start date: 2020-08-17
• Primary completion: 2021-12-31
• Completion: 2022-02-28
• First posted: 2020-08-12
• Last updated: 2020-08-12

Locations

1 site across 1 country: Finland