Iron Deficiency as an Ignored Cause of Infertility

Phase 4

• Conditions: Iron Deficiency; Infertility
• Interventions: Drug: Ferric Carboxymaltose Injection; Drug: NaCl infusion

• Registration Number: NCT04510870
• Lead Sponsor: Dextra Fertility Clinic

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-09
• Study First Submitted QC: 2020-08-11
• Last Update Submitted: 2020-08-11
• Study First Posted: 2020-08-12
• Last Update Posted: 2020-08-12
• Study Start: 2020-08-17
• Primary Completion: 2021-12-31
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental group	Ferric Carboxymaltose Injection	1. infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC) 2. infusion is NaCl
NaCl infusion group	Ferric Carboxymaltose Injection	1. infusion is NaCl 2. infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC)
Experimental group	NaCl infusion	1. infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC) 2. infusion is NaCl
NaCl infusion group	NaCl infusion	1. infusion is NaCl 2. infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dextra Fertility Clinic; 🇫🇮 Helsinki, Finland