Assisted ReproductionNCT05783349
Predictive Value of Th1, Th2 and Th17 Cytokines on the Success of Embryo Implantation (ImmuNoFertilité)
A study testing Unique blod sample in people with Assisted Reproduction, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Infertility affects approximately 10-15% of the population. The number of assisted reproduction procedures has increased by a factor of 3 to 5.3 worldwide over the last 20 years. Despite recent techniques, pregnancy rates seem to be limited to 35% by embryo transfer. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Assisted Reproduction
- What is being tested?
- Unique blod sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2023to 23 Feb 2024
- Phase
- Interventional
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult women (aged 18 and above) treated in the Medically Assisted Procreation (MAP) center of the University Hospital of Nice, in the process of a frozen embryo transfer
- Social security affiliation
- Signed consent
Who cannot join
- Contra-indication to frozen embryo transfer
- Ongoing infection
- Patients under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Study the Predictive Value of Th1, Th2 and Th17 Cytokine Serum Levels Produced After Non-specific Stimulation on the Success of Embryo Implantation
Infertility affects approximately 10-15% of the population. The number of assisted reproduction procedures has increased by a factor of 3 to 5.3 worldwide over the last 20 years. Despite recent techniques, pregnancy rates seem to be limited to 35% by embryo transfer. Embryo implantation depends on two factors: the quality of the embryo and the endometrial receptivity. Although good quality embryos are transferred, implantation may not occur. Changes in the maternal cytokine profile at the time of implantation may result in poor implantation or early abortions. Consequently, a misdirection of the immunological profile could be responsible for repeated implantation failure (RIF). The definition of RIF is not consensual, but most commonly refers to 3 failures after good quality embryo transfer, and would affect between 5 and 10% of patients.
The possibility of defining a predictive immune profile for RIF from a peripheral blood sample is debated. However, after stimulation of immune cells in peripheral blood, patients with RIF show an excessive pro-inflammatory profile.
Our objective is to assess the activation of T cells and innate immune cells (via an anti-CD3 agonist and a TLR7-8 ligand, respectively) from a blood sample to predict implantation success after frozen embryo transfer. This functional test is easy to use and applicable in a clinical routine.
- Conditions
- Assisted Reproduction
- Being tested
- Unique blod sample
- Keywords
- Repeated Implantation Failure (RIF), Embryo implantation, T cells activation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unique blod sampleBiological
sampling of 4mL of blood on lithium heparin tube, the day of frozen embryo implantation
| Study group | Role | What they receive |
|---|---|---|
| Women treated in the Medically Assisted Procreation (MAP) center of Nice | Other | Not described Receives: Biological: Unique blod sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ex vivo comparison of the immune profile between patients with Repeated Implantation Failure and patients with successful implantation.
The immune profiles are defined as the concentrations (in IU/mL or pg/mL) and ratios of proinflammatory and anti-inflammatory cytokines measured after nonspecific stimulation of peripheral blood cells from each patient: IFNγ, IL6, IL1β, TNFα, IL4, IL10, TGFβ, IFNγ/IL4, IFNγ/IL10, IFNγ/TGFβ, IL6/IL4, IL6/IL10, IL6/TGFβ, IL1β/IL4, IL1β/IL10, IL1β/TGFβ, TNFα/IL4, TNFα/IL10, TNFα/TGFβ.
Measured: 24 months
Secondary outcomes (3)
Ex vivo comparison of the immune profile between patients with one implantation failure and patients with successful implantation.
The immune profiles are defined as the concentrations (in IU/mL or pg/mL) and ratios of proinflammatory and anti-inflammatory cytokines measured after nonspecific stimulation of peripheral blood cells from each patient: IFNγ, IL6, IL1β, TNFα, IL4, IL10, TGFβ, IFNγ/IL4, IFNγ/IL10, IFNγ/TGFβ, IL6/IL4, IL6/IL10, IL6/TGFβ, IL1β/IL4, IL1β/IL10, IL1β/TGFβ, TNFα/IL4, TNFα/IL10, TNFα/TGFβ.
Measured: 24 months
Ex vivo comparison of the immune profile between patients with one implantation failure in the context of inflammatory disorder (such as endometriosis) and patients with successful implantation.
The immune profiles are defined as the concentrations (in IU/mL or pg/mL) and ratios of proinflammatory and anti-inflammatory cytokines measured after nonspecific stimulation of peripheral blood cells from each patient: IFNγ, IL6, IL1β, TNFα, IL4, IL10, TGFβ, IFNγ/IL4, IFNγ/IL10, IFNγ/TGFβ, IL6/IL4, IL6/IL10, IL6/TGFβ, IL1β/IL4, IL1β/IL10, IL1β/TGFβ, TNFα/IL4, TNFα/IL10, TNFα/TGFβ.
Measured: 24 months
Ex vivo comparison of the immune profile between patients with a pregnancy failure and patients with an active pregnancy at the end of the first trimester.
The immune profiles are defined as the concentrations (in IU/mL or pg/mL) and ratios of proinflammatory and anti-inflammatory cytokines measured after nonspecific stimulation of peripheral blood cells from each patient: IFNγ, IL6, IL1β, TNFα, IL4, IL10, TGFβ, IFNγ/IL4, IFNγ/IL10, IFNγ/TGFβ, IL6/IL4, IL6/IL10, IL6/TGFβ, IL1β/IL4, IL1β/IL10, IL1β/TGFβ, TNFα/IL4, TNFα/IL10, TNFα/TGFβ.
Pregnancy test: βhCG concentration on blood sample in IU/L. Result of the ultrasound performed routinely during the first trimester (between 4 and 11 amenorrhea weeks): presence or absence of intrauterine pregnancy , progressive or not.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start4 May 2023
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assisted ReproductionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783349
- Sponsor's protocol ID
- 22-PP-17
- Status last verified
- Nov 2024
- First submitted
- 10 Feb 2023
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing data is not planned
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Predictive Value of Th1, Th2 and Th17 Cytokine Serum Levels Produced After Non-specific Stimulation on the Success of Embryo Implantation
- ClinicalTrials.gov ID
- NCT05783349
- Acronym / sponsor ID
- 22-PP-17
- Conditions
- Assisted Reproduction
- Keywords
- Repeated Implantation Failure (RIF), Embryo implantation, T cells activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 24 Mar 2023 (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.
Infertility affects approximately 10-15% of the population. The number of assisted reproduction procedures has increased by a factor of 3 to 5.3 worldwide over the last 20 years. Despite recent techniques, pregnancy rates seem to be limited to 35% by embryo transfer. Embryo implantation depends on two factors: the quality of the embryo and the endometrial receptivity. Although good quality embryos are transferred, implantation may not occur. Changes in the maternal cytokine profile at the time of implantation may result in poor implantation or early abortions. Consequently, a misdirection of the immunological profile could be responsible for repeated implantation failure (RIF). The definition of RIF is not consensual, but most commonly refers to 3 failures after good quality embryo transfer, and would affect between 5 and 10% of patients.
The possibility of defining a predictive immune profile for RIF from a peripheral blood sample is debated. However, after stimulation of immune cells in peripheral blood, patients with RIF show an excessive pro-inflammatory profile.
Our objective is to assess the activation of T cells and innate immune cells (via an anti-CD3 agonist and a TLR7-8 ligand, respectively) from a blood sample to predict implantation success after frozen embryo transfer. This functional test is easy to use and applicable in a clinical routine.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women treated in the Medically Assisted Procreation (MAP) center of Nice | Other | Biological: Unique blod sample |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult women (aged 18 and above) treated in the Medically Assisted Procreation (MAP) center of the University Hospital of Nice, in the process of a frozen embryo transfer
- Social security affiliation
- Signed consent
Key exclusion criteria (3 listed)
- Contra-indication to frozen embryo transfer
- Ongoing infection
- Patients under guardianship
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 |
|---|---|---|
| Unique blod samplesampling of 4mL of blood on lithium heparin tube, the day of frozen embryo implantation | Biological | Women treated in the Medically Assisted Procreation (MAP) center of Nice |
Primary outcome
Ex vivo comparison of the immune profile between patients with Repeated Implantation Failure and patients with successful implantation.
Time frame: 24 months
The immune profiles are defined as the concentrations (in IU/mL or pg/mL) and ratios of proinflammatory and anti-inflammatory cytokines measured after nonspecific stimulation of peripheral blood cells from each patient: IFNγ, IL6, IL1β, TNFα, IL4, IL10, TGFβ, IFNγ/IL4, IFNγ/IL10, IFNγ/TGFβ, IL6/IL4, IL6/IL10, IL6/TGFβ, IL1β/IL4, IL1β/IL10, IL1β/TGFβ, TNFα/IL4, TNFα/IL10, TNFα/TGFβ.
3 secondary outcomes
Ex vivo comparison of the immune profile between patients with one implantation failure and patients with successful implantation.
Time frame: 24 months
Ex vivo comparison of the immune profile between patients with one implantation failure in the context of inflammatory disorder (such as endometriosis) and patients with successful implantation.
Time frame: 24 months
Ex vivo comparison of the immune profile between patients with a pregnancy failure and patients with an active pregnancy at the end of the first trimester.
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No. Sharing data is not planned
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unique blod sample in people with Assisted Reproduction, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 18 Nov 2024. 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 France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ex vivo comparison of the immune profile between patients with Repeated Implantation Failure and patients with successful implantation. (time frame: 24 months). 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 18 Nov 2024.