Iron Deficiency as an Ignored Cause of Infertility (IDI)

Dextra Fertility Clinic

Status and phase: Unknown; Phase 4

Conditions: Iron Deficiency; Infertility

Treatments: Drug: Ferric Carboxymaltose Injection; Drug: NaCl infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04510870

2019-002040-24 (EudraCT Number)

FI028.DEX001.2019

KLnro136/2019 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 62 estimated patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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62 participants in 2 patient groups

Experimental group

Experimental group

Description:

1. infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC) 2. infusion is NaCl

Treatment:

Drug: Ferric Carboxymaltose Injection

Drug: NaCl infusion

NaCl infusion group

Experimental group

Description:

1. infusion is NaCl 2. infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC)

Treatment:

Drug: Ferric Carboxymaltose Injection

Drug: NaCl infusion