Iron DeficiencyPhase 4IDINCT04510870
Iron Deficiency as an Ignored Cause of Infertility
A Phase 4 study testing Ferric Carboxymaltose Injection and NaCl infusion in people with Iron Deficiency and Infertility, run by Dextra Fertility Clinic at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Iron Deficiency, Infertility
- What is being tested?
- Ferric Carboxymaltose Injection and NaCl infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFinland
- Study dates
- 17 Aug 2020to 28 Feb 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- Endometriosis
- Poor responder
- Inflammatory bowel disease (IBD), colitis ulcerosa
- Rheumatoid arthritis
- Renal insufficiency
- Cardiac insufficiency
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- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
Dextra Fertility Clinic
Helsinki, 00180
Annika Tulenheimo-Silfvast, M.D., +358503507991, annika.tulenheimo-silfvast@dextra.fi
About this study
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).
- Conditions
- Iron Deficiency, Infertility
- Being tested
- Ferric Carboxymaltose Injection, NaCl infusion
- Keywords
- low ferritin, infertility, in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), assisted reproductive technology (ART)
- Medical subject headings
- Iron Deficiencies, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric Carboxymaltose InjectionDrug
Also called Ferinject
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 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 1. infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC)
2. infusion is NaCl Receives: Drug: Ferric Carboxymaltose Injection; Drug: NaCl infusion |
| NaCl infusion group | Experimental | 1. infusion is NaCl
2. infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC) Receives: Drug: Ferric Carboxymaltose Injection; Drug: NaCl infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of good quality blastocysts
good quality blastocyst are defined as blastocyst, which are transferable or may be frozen
Measured: day 5-7 after oocyte pick up
Secondary outcomes (5)
blastulation rate
number of blastocysts /fertilized oocyte
Measured: day 5-7 after oocyte pick up
ongoing pregnancy/ pregnancy rate
ongoing pregnancy at 12 weeks of gestation/ positive pregnancy test (%)
Measured: 10 weeks after oocyte pick up,at oocyte pick up it counted to be 2 weeks of gestation.
mature oocyte rate
number of mature oocytes / total number of oocytes (%)
Measured: 1 day after oocyte pick up
fertilization rate
number of fertilized oocytes/total number of oocytes (%)
Measured: 1 day after oocyte pick up
implantation rate
number of attached embryos/ embryo transfer (%)
Measured: 5 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start17 Aug 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dextra Fertility Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annika Tulenheimo-Silfvast, M.D, Principal investigator, senior consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510870
- Sponsor's protocol ID
- FI028.DEX001.2019
- Other IDs
- 2019-002040-24, KLnro136/2019, 2019
- Acronym
- IDI
- Status last verified
- Aug 2020
- First submitted
- 9 Aug 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Deficiency as an Ignored Cause of Infertility
- ClinicalTrials.gov ID
- NCT04510870
- Acronym / sponsor ID
- IDI / FI028.DEX001.2019
- Conditions
- Iron Deficiency, Infertility
- Keywords
- low ferritin, infertility, in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), assisted reproductive technology (ART)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Dextra Fertility ClinicUniversity, hospital or other
- Study start
- 17 Aug 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Ferric Carboxymaltose Injection, Drug: NaCl infusion1. infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC) 2. infusion is NaCl |
| NaCl infusion group | Experimental | Drug: Ferric Carboxymaltose Injection, Drug: NaCl infusion1. infusion is NaCl 2. infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC) |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- Endometriosis
- Poor responder
- Inflammatory bowel disease (IBD), colitis ulcerosa
- Rheumatoid arthritis
- Renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric Carboxymaltose InjectionAlso: FerinjectInfusion 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. | Drug | Experimental group, NaCl infusion group |
| NaCl infusionPlacebo 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. | Drug | Experimental group, NaCl infusion group |
Primary outcome
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
5 secondary outcomes
blastulation rate
Time frame: day 5-7 after oocyte pick up
ongoing pregnancy/ pregnancy rate
Time frame: 10 weeks after oocyte pick up,at oocyte pick up it counted to be 2 weeks of gestation.
mature oocyte rate
Time frame: 1 day after oocyte pick up
fertilization rate
Time frame: 1 day after oocyte pick up
implantation rate
Time frame: 5 weeks after embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
Related trials for Iron Deficiency
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Iron Absorption From a Nutritional Iron Supplement
Iron Absorption, Iron Deficiencies
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The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
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The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annika Tulenheimo-Silfvast, M.D principal investigator
senior consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric Carboxymaltose Injection and NaCl infusion in people with Iron Deficiency and Infertility, run by Dextra Fertility Clinic at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annika Tulenheimo-Silfvast, M.D. (+358503507991, annika.tulenheimo-silfvast@fimnet.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of good quality blastocysts (time frame: day 5-7 after oocyte pick up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.