Trial | NCT04510870  Report issue

Official Title

Iron Deficiency as an Ignored Cause of Infertility

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    62
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).
Study Started
Aug 17
2020
Anticipated
Primary Completion
Dec 31
2021
Anticipated
Study Completion
Feb 28
2022
Anticipated
Last Update
Aug 12
2020

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.

  • Other names: Ferinject

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.

Experimental group Experimental

infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC) infusion is NaCl

NaCl infusion group Experimental

infusion is NaCl infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC)

Criteria 

Inclusion Criteria:

Patient's 18 to 42 years and in full consent
Ferritin ≤ 30 ug/l
Anti-mullerian hormone (AMH) > 1ug/l
Planned for IVF/ ICSI treatment
Diagnosis for treatment: tubal factor, male factor or unexplained infertility (NUD)

Exclusion Criteria:

Endometriosis
Poor responder
Inflammatory bowel disease (IBD), colitis ulcerosa
Rheumatoid arthritis
Renal insufficiency
Cardiac insufficiency
Body Mass Index (BMI) over 35
Known hypersensitivity to the active substance, to ferric carboxymaltose or any of its excipients, or to other parental iron products
Clinical evidence of iron overload or disturbances in the utilization of iron
use of atosiban or filgrastim during stimulation or embryo transfer
No Results Posted