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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002040-24 | EudraCT Number | ||
| KLnro136/2019 | Other Identifier | Finnish Medicines Agency FIMEA |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental |
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| NaCl infusion group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric Carboxymaltose Injection | Drug | 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. |
| 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 |
| 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 (%) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
evaluates female part in reproduction
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annika Tulenheimo-Silfvast, M.D. | Contact | +358503507991 | annika.tulenheimo-silfvast@fimnet.fi | |
| Niklas Simberg, Ass.prof. | Contact | +3584125152020 | niklas.simberg@dextra.fi |
| Name | Affiliation | Role |
|---|---|---|
| Annika Tulenheimo-Silfvast, M.D | senior consultant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dextra Fertility Clinic | Helsinki | 00180 | Finland |
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
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| NaCl infusion | Drug | 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. |
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| 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 |
| D000091642 | Urogenital Diseases |