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Iron Deficiency as an Ignored Cause of Infertility (IDI)

Primary Purpose

Iron Deficiency, Infertility

Status
Unknown status
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Ferric Carboxymaltose Injection
NaCl infusion
Sponsored by
Dextra Fertility Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency focused on measuring low ferritin, infertility, in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), assisted reproductive technology (ART)

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dextra Fertility Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Experimental group

NaCl infusion group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of good quality blastocysts
good quality blastocyst are defined as blastocyst, which are transferable or may be frozen

Secondary Outcome Measures

blastulation rate
number of blastocysts /fertilized oocyte
ongoing pregnancy/ pregnancy rate
ongoing pregnancy at 12 weeks of gestation/ positive pregnancy test (%)
mature oocyte rate
number of mature oocytes / total number of oocytes (%)
fertilization rate
number of fertilized oocytes/total number of oocytes (%)
implantation rate
number of attached embryos/ embryo transfer (%)

Full Information

First Posted
August 9, 2020
Last Updated
August 11, 2020
Sponsor
Dextra Fertility Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04510870
Brief Title
Iron Deficiency as an Ignored Cause of Infertility
Acronym
IDI
Official Title
Iron Deficiency as an Ignored Cause of Infertility
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 17, 2020 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dextra Fertility Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency, Infertility
Keywords
low ferritin, infertility, in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), assisted reproductive technology (ART)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC) infusion is NaCl
Arm Title
NaCl infusion group
Arm Type
Experimental
Arm Description
infusion is NaCl infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC)
Intervention Type
Drug
Intervention Name(s)
Ferric Carboxymaltose Injection
Other Intervention Name(s)
Ferinject
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
NaCl infusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of good quality blastocysts
Description
good quality blastocyst are defined as blastocyst, which are transferable or may be frozen
Time Frame
day 5-7 after oocyte pick up
Secondary Outcome Measure Information:
Title
blastulation rate
Description
number of blastocysts /fertilized oocyte
Time Frame
day 5-7 after oocyte pick up
Title
ongoing pregnancy/ pregnancy rate
Description
ongoing pregnancy at 12 weeks of gestation/ positive pregnancy test (%)
Time Frame
10 weeks after oocyte pick up,at oocyte pick up it counted to be 2 weeks of gestation.
Title
mature oocyte rate
Description
number of mature oocytes / total number of oocytes (%)
Time Frame
1 day after oocyte pick up
Title
fertilization rate
Description
number of fertilized oocytes/total number of oocytes (%)
Time Frame
1 day after oocyte pick up
Title
implantation rate
Description
number of attached embryos/ embryo transfer (%)
Time Frame
5 weeks after embryo transfer
Other Pre-specified Outcome Measures:
Title
endometrial thickness
Description
difference of endometrial thickness in mm compared at the day of infusion and the day of embryo transfer
Time Frame
1 month after infusion, at the time of embryo transfer

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
evaluates female part in reproduction
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annika Tulenheimo-Silfvast, M.D.
Phone
+358503507991
Email
annika.tulenheimo-silfvast@fimnet.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Niklas Simberg, Ass.prof.
Phone
+3584125152020
Email
niklas.simberg@dextra.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annika Tulenheimo-Silfvast, M.D
Organizational Affiliation
senior consultant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dextra Fertility Clinic
City
Helsinki
ZIP/Postal Code
00180
Country
Finland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annika Tulenheimo-Silfvast, M.D.
Phone
+358503507991
Email
annika.tulenheimo-silfvast@dextra.fi

12. IPD Sharing Statement

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Iron Deficiency as an Ignored Cause of Infertility

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