Iron Deficiency as an Ignored Cause of Infertility

• Status: Not yet recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dextra Fertility Clinic
• Treatments: Ferric Compounds

Criteria

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