We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Iron Deficiency as an Ignored Cause of Infertility (IDI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04510870
Recruitment Status : Unknown
Verified August 2020 by Dextra Fertility Clinic.
Recruitment status was:  Not yet recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Dextra Fertility Clinic

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).


Condition or disease Intervention/treatment Phase
Iron Deficiency Infertility Drug: Ferric Carboxymaltose Injection Drug: NaCl infusion Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Iron Deficiency as an Ignored Cause of Infertility
Estimated Study Start Date : August 17, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility Iron

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Experimental group
  1. infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC)
  2. infusion is NaCl
 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.
Other Name: Ferinject

Drug: 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.
Experimental: NaCl infusion group
  1. infusion is NaCl
  2. infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC)
 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.
Other Name: Ferinject

Drug: 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of good quality blastocysts [ Time Frame: day 5-7 after oocyte pick up ]
    good quality blastocyst are defined as blastocyst, which are transferable or may be frozen


Secondary Outcome Measures :
  1. blastulation rate [ Time Frame: day 5-7 after oocyte pick up ]
    number of blastocysts /fertilized oocyte

  2. ongoing pregnancy/ pregnancy rate [ Time Frame: 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 (%)

  3. mature oocyte rate [ Time Frame: 1 day after oocyte pick up ]
    number of mature oocytes / total number of oocytes (%)

  4. fertilization rate [ Time Frame: 1 day after oocyte pick up ]
    number of fertilized oocytes/total number of oocytes (%)

  5. implantation rate [ Time Frame: 5 weeks after embryo transfer ]
    number of attached embryos/ embryo transfer (%)


Other Outcome Measures:
  1. endometrial thickness [ Time Frame: 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   evaluates female part in reproduction
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510870


Contacts
Layout table for location contacts
Contact: Annika Tulenheimo-Silfvast, M.D. +358503507991 annika.tulenheimo-silfvast@fimnet.fi
Contact: Niklas Simberg, Ass.prof. +3584125152020 niklas.simberg@dextra.fi

Locations
Layout table for location information
Finland
Dextra Fertility Clinic
Helsinki, Finland, 00180
Contact: Annika Tulenheimo-Silfvast, M.D.    +358503507991    annika.tulenheimo-silfvast@dextra.fi   
Sponsors and Collaborators
Dextra Fertility Clinic
Investigators
Layout table for investigator information
Principal Investigator: Annika Tulenheimo-Silfvast, M.D senior consultant
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Dextra Fertility Clinic
ClinicalTrials.gov Identifier: NCT04510870    
Other Study ID Numbers: FI028.DEX001.2019
2019-002040-24 ( EudraCT Number )
KLnro136/2019 ( Other Identifier: Finnish Medicines Agency FIMEA )
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dextra Fertility Clinic:
low ferritin
infertility
in vitro fertilization (IVF)
intracytoplasmic sperm injection (ICSI)
assisted reproductive technology (ART)
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
 Iron Metabolism Disorders
Metabolic Diseases
Ferric Compounds
Hematinics