Iron Deficiency as an Ignored Cause of Infertility

Infertility Clinical Trial

— IDI  

Official title:

Iron Deficiency as an Ignored Cause of Infertility

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04510870
• Other study ID #: FI028.DEX001.2019
• Secondary ID: 2019-002040-24KL
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 17, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: August 2020
• Source: Dextra Fertility Clinic
• Contact: Annika Tulenheimo-Silfvast, M.D.
• Phone: +358503507991
• Email: annika.tulenheimo-silfvast[@]fimnet.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: February 28, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Infertility
• Iron Deficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
Finland	Dextra Fertility Clinic	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Dextra Fertility Clinic

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	blastulation rate	number of blastocysts /fertilized oocyte	day 5-7 after oocyte pick up
Secondary	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.
Secondary	mature oocyte rate	number of mature oocytes / total number of oocytes (%)	1 day after oocyte pick up
Secondary	fertilization rate	number of fertilized oocytes/total number of oocytes (%)	1 day after oocyte pick up
Secondary	implantation rate	number of attached embryos/ embryo transfer (%)	5 weeks after embryo transfer