Iron Deficiency as an Ignored Cause of Infertility

Study Overview
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Brief Summary
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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).

Official Title
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Iron Deficiency as an Ignored Cause of Infertility

Conditions
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Iron Deficiency, Infertility

Intervention / Treatment
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* Drug: Ferric Carboxymaltose Injection
* Drug: NaCl infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC) infusion is NaCl | Drug: Ferric Carboxymaltose Injection<br>* 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.<br>* Other names: Ferinject;Drug: NaCl infusion<br>* 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.<br>|
| Experimental: NaCl infusion group<br>infusion is NaCl infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC) | Drug: Ferric Carboxymaltose Injection<br>* 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.<br>* Other names: Ferinject;Drug: NaCl infusion<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low ferritin, infertility, in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), assisted reproductive technology (ART)