Iron Deficiency as an Ignored Cause of Infertility (IDI)

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 Overview

• Status: Unknown
• Conditions: Infertility; Iron Deficiency
• Intervention / Treatment: Drug: Ferric Carboxymaltose Injection; Drug: NaCl infusion

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Annika Tulenheimo-Silfvast, M.D.; Phone Number: +358503507991; Email: annika.tulenheimo-silfvast@fimnet.fi
• Study Contact Backup: Name: Niklas Simberg, Ass.prof.; Phone Number: +3584125152020; Email: niklas.simberg@dextra.fi

Study Locations

• Finland
  • Helsinki, Finland, 00180
    • Dextra Fertility Clinic
    • Contact: Annika Tulenheimo-Silfvast, M.D.; Phone Number: +358503507991; Email: annika.tulenheimo-silfvast@dextra.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC); infusion is NaCl	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: NaCl infusion group; infusion is NaCl; infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of good quality blastocysts	good quality blastocyst are defined as blastocyst, which are transferable or may be frozen	day 5-7 after oocyte pick up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blastulation rate	number of blastocysts /fertilized oocyte	day 5-7 after oocyte pick up
ongoing pregnancy/ pregnancy rate	ongoing pregnancy at 12 weeks of gestation/ positive pregnancy test (%)	10 weeks after oocyte pick up,at oocyte pick up it counted to be 2 weeks of gestation.
mature oocyte rate	number of mature oocytes / total number of oocytes (%)	1 day after oocyte pick up
fertilization rate	number of fertilized oocytes/total number of oocytes (%)	1 day after oocyte pick up
implantation rate	number of attached embryos/ embryo transfer (%)	5 weeks after embryo transfer

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
endometrial thickness	difference of endometrial thickness in mm compared at the day of infusion and the day of embryo transfer	1 month after infusion, at the time of embryo transfer

Collaborators and Investigators

• Sponsor: Dextra Fertility Clinic
• Investigators: Principal Investigator: Annika Tulenheimo-Silfvast, M.D, Senior Consultant

Study record dates

Study Major Dates

• Study Start (Anticipated): August 17, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: August 9, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (Actual): August 12, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: infertility; assisted reproductive technology (ART); low ferritin; in vitro fertilization (IVF); intracytoplasmic sperm injection (ICSI)
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Infertility; Anemia, Iron-Deficiency; Hematinics; Ferric Compounds
• Other Study ID Numbers: FI028.DEX001.2019; 2019-002040-24 (EudraCT Number); KLnro136/2019 (Other Identifier: Finnish Medicines Agency FIMEA)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No