NCT04510870

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

August 17, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

1.4 years

First QC Date

August 9, 2020

Last Update Submit

August 11, 2020

Conditions

Iron DeficiencyInfertility

Keywords

low ferritininfertilityin vitro fertilization (IVF)intracytoplasmic sperm injection (ICSI)assisted reproductive technology (ART)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • blastulation rate

    day 5-7 after oocyte pick up

  • ongoing pregnancy/ pregnancy rate

    10 weeks after oocyte pick up,at oocyte pick up it counted to be 2 weeks of gestation.

  • mature oocyte rate

    1 day after oocyte pick up

  • fertilization rate

    1 day after oocyte pick up

  • implantation rate

    5 weeks after embryo transfer

Other Outcomes (1)

  • endometrial thickness

    1 month after infusion, at the time of embryo transfer

Study Arms (2)

Experimental group

EXPERIMENTAL

1. infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC) 2. infusion is NaCl

Drug: Ferric Carboxymaltose InjectionDrug: NaCl infusion

NaCl infusion group

EXPERIMENTAL

1. infusion is NaCl 2. infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC)

Drug: Ferric Carboxymaltose InjectionDrug: NaCl infusion

Interventions

Ferric Carboxymaltose InjectionDRUG

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.

Also known as: Ferinject
Experimental groupNaCl infusion group
NaCl infusionDRUG

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.

Experimental groupNaCl infusion group

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsevaluates female part in reproduction
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dextra Fertility Clinic

Helsinki, 00180, Finland

Location

MeSH Terms

Conditions

Iron DeficienciesInfertility

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGenital DiseasesUrogenital Diseases

Study Officials

  • Annika Tulenheimo-Silfvast, M.D

    senior consultant

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annika Tulenheimo-Silfvast, M.D.

CONTACT

+358503507991annika.tulenheimo-silfvast@fimnet.fi

Niklas Simberg, Ass.prof.

CONTACT

+3584125152020niklas.simberg@dextra.fi

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2020

First Posted

August 12, 2020

Study Start

August 17, 2020

Primary Completion

December 31, 2021

Study Completion

February 28, 2022

Last Updated

August 12, 2020

Record last verified: 2020-08

Locations

FI(1)