Iron Deficiency, Infertility
Conditions
Keywords
low ferritin, infertility, in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), assisted reproductive technology (ART)
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).
Interventions
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.
DRUGNaCl 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.
Sponsors
Dextra Fertility Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 (%) |
| 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 (%) |
| mature oocyte rate | 1 day after oocyte pick up | number of mature oocytes / total number of oocytes (%) |
Other
| Measure | Time frame | Description |
|---|---|---|
| endometrial thickness | 1 month after infusion, at the time of embryo transfer | difference of endometrial thickness in mm compared at the day of infusion and the day of embryo transfer |
Countries
Finland
Contacts
Primary ContactAnnika Tulenheimo-Silfvast, M.D.
Backup ContactNiklas Simberg, Ass.prof.
Outcome results
None listed