Infertility, FemaleNCT04753736
Immunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC
A study testing Intrauterine administration of hCG-activated peripheral blood mononuclear cells in people with Infertility, Female, run by Fertilys at 1 site in Canada.
Trial summary
The purpose of this study is to identify a systemic immunological profile specific to patients with recurrent implantation failures (RIF) or miscarriages (RM) through blood immunophenotyping on the day of ovulation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Intrauterine administration of hCG-activated peripheral blood mononuclear cells
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 24 Sep 2021to 1 Nov 2021
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All women aged 18 and over undergoing an IVF cycle with her partner's sperm at the Fertilys fertility center, without a RIF status, agreeing to participate in the study and having signed the consent form to participate in the study.
- All women aged 18 and over undergoing an IVF cycle with her partner's sperm at the Fertilys fertility center, with a RIF or RM status, agreeing to participate in the study and having signed the consent form to participate in the study.
Who cannot join
- Women who need a gametes donor (eggs and / or sperm).
- Women undergoing an IVF cycle with frozen sperm.
- Women with autoimmune disease.
- Women with diabetes.
- Women with a history of chemotherapy treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrauterine Administration and Immunophenotyping of Autologous Peripheral Blood Mononuclear Cells in Patients With Repeated Implantation Failures During Undergoing in Vitro Fertilization Treatment
The purpose of this study is to identify a systemic immunological profile specific to patients with recurrent implantation failures (RIF) or miscarriages (RM) through blood immunophenotyping on the day of ovulation. This study also aims to determine whether the intrauterine administration of 5 million peripheral blood monocluear cells increases implantation and pregnancy rates in patients with RIF and decreases the risk of miscarriages in patients with RM, compared to what has already been published in the scientific literature
- Conditions
- Infertility, Female
- Being tested
- Intrauterine administration of hCG-activated peripheral blood mononuclear cells
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine administration of hCG-activated peripheral blood mononuclear cellsProcedure or surgery
Intrauterine administration of hCG-activated peripheral blood mononuclear cells
| Study group | Role | What they receive |
|---|---|---|
| No recurrent implantation failure | No intervention | Not described |
| Recurrent implantation failures | Experimental | Not described Receives: Procedure: Intrauterine administration of hCG-activated peripheral blood mononuclear cells |
| Recurrent miscarriage | Experimental | Not described Receives: Procedure: Intrauterine administration of hCG-activated peripheral blood mononuclear cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryo implantation rate (biochemical pregnancy)
Measured: Two weeks following embryo transfer or 3 weeks following intrauterine insemination
Clinical pregnancy rate
Measured: Six to 8 weeks of gestation
Secondary outcomes (3)
Peripheral blood mononuclear cells populations (PBMC) distribution at Day 0
Measured: The day 0 of the patient's ovulation
Peripheral blood mononuclear cells populations distribution at Day 2
Measured: After 48 hours of culture
Cytokines (LIF, IL-6, IL-10, TNFα, FGF-2, VEGF, IL-8) quantification by ELISA in PBMC culture medium at Day 2
Measured: After 48 hours of culture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start24 Sep 2021
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Why it stopped: lack of staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fertilys
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753736
- Sponsor's protocol ID
- Immunophenotypage RIF and RM
- Status last verified
- Sep 2023
- First submitted
- 11 Feb 2021
- Last updated
- 18 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrauterine Administration and Immunophenotyping of Autologous Peripheral Blood Mononuclear Cells in Patients With Repeated Implantation Failures During Undergoing in Vitro Fertilization Treatment
- ClinicalTrials.gov ID
- NCT04753736
- Acronym / sponsor ID
- Immunophenotypage RIF and RM
- Conditions
- Infertility, Female
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of staff
- Enrolment
- 0 participants (actual)
- Lead sponsor
- FertilysIndustry (pharma, biotech, devices)
- Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM)
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 15 Feb 2021 (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.
The purpose of this study is to identify a systemic immunological profile specific to patients with recurrent implantation failures (RIF) or miscarriages (RM) through blood immunophenotyping on the day of ovulation. This study also aims to determine whether the intrauterine administration of 5 million peripheral blood monocluear cells increases implantation and pregnancy rates in patients with RIF and decreases the risk of miscarriages in patients with RM, compared to what has already been published in the scientific literature
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No recurrent implantation failure | No intervention | – |
| Recurrent implantation failures | Experimental | Procedure: Intrauterine administration of hCG-activated peripheral blood mononuclear cells |
| Recurrent miscarriage | Experimental | Procedure: Intrauterine administration of hCG-activated peripheral blood mononuclear cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All women aged 18 and over undergoing an IVF cycle with her partner's sperm at the Fertilys fertility center, without a RIF status, agreeing to participate in the study and having signed the consent form to participate in the study.
- All women aged 18 and over undergoing an IVF cycle with her partner's sperm at the Fertilys fertility center, with a RIF or RM status, agreeing to participate in the study and having signed the consent form to participate in the study.
Key exclusion criteria (5 listed)
- Women who need a gametes donor (eggs and / or sperm).
- Women undergoing an IVF cycle with frozen sperm.
- Women with autoimmune disease.
- Women with diabetes.
- Women with a history of chemotherapy treatment.
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 |
|---|---|---|
| Intrauterine administration of hCG-activated peripheral blood mononuclear cellsIntrauterine administration of hCG-activated peripheral blood mononuclear cells | Procedure or surgery | Recurrent implantation failures, Recurrent miscarriage |
Primary outcome
Embryo implantation rate (biochemical pregnancy)
Time frame: Two weeks following embryo transfer or 3 weeks following intrauterine insemination
Clinical pregnancy rate
Time frame: Six to 8 weeks of gestation
3 secondary outcomes
Peripheral blood mononuclear cells populations (PBMC) distribution at Day 0
Time frame: The day 0 of the patient's ovulation
Peripheral blood mononuclear cells populations distribution at Day 2
Time frame: After 48 hours of culture
Cytokines (LIF, IL-6, IL-10, TNFα, FGF-2, VEGF, IL-8) quantification by ELISA in PBMC culture medium at Day 2
Time frame: After 48 hours of culture
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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 Intrauterine administration of hCG-activated peripheral blood mononuclear cells in people with Infertility, Female, run by Fertilys at 1 site in Canada.
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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 18 Sep 2023. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Embryo implantation rate (biochemical pregnancy) (time frame: Two weeks following embryo transfer or 3 weeks following intrauterine insemination). The study lists 2 primary outcomes in all. 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 Sep 2023.