Infertility (IVF Patients)R-IMinARTNCT06709976
ReceptIVFity & Immunology in ART
An observational study of Infertility (IVF Patients) and Infertility Assisted Reproductive Technology, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The goal of this clinical non-invasive observational pilot study is to improve the prediction of pregnancy success after In Vitro Fertilisation (IVF)/IVF -Intracytoplasmic Sperm Injection (ICSI) treatment by examining the vaginal microbiome and the immunological profile of menstrual blood in women (18-42) years old)… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility (IVF Patients), Infertility Assisted Reproductive Technology
- What is being tested?
- Vaginal microbiome swab and Menstrual Blood Collection via Menstrual Cup
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Sep 2024to 1 Dec 2025
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult
Study population: Women aged 18-42 expected to undergo their first IVF/IVF-ICSI cycle within the next two months. The routine IVF/IVF-ICSI procedure will occur irrespective of their participation or the test outcomes.
Who may be able to join
- Indication for an IVF or IVF/ICSI procedure.
- 18 years - 42 years.
- European origin
- Willing to provide a vaginal swab with the ReceptIVFity-test.
- Willing to provide informed consent.
Who cannot join
- No transferable embryos after IVF or IVF/ICSI.
- Emergency IVF for cancer or other reasons.
- Women with endometriosis pre-treated with an Gn-RH analogue.
- The use of (hormonal) contraceptives or antibiotics 3 months prior to start IVF or IVF/ICSI.
- Women unable or unwilling to agree with the procedures.
- Women unable or unwilling to give written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing the Accuracy to Predict Pregnancy Success After Assisted Reproductive Therapy (ART) by Combining the ReceptIVFIty Test with Immunological Parameters
The goal of this clinical non-invasive observational pilot study is to improve the prediction of pregnancy success after In Vitro Fertilisation (IVF)/IVF -Intracytoplasmic Sperm Injection (ICSI) treatment by examining the vaginal microbiome and the immunological profile of menstrual blood in women (18-42) years old) undergoing their first IVF/IVF/ICSI treatment.
The main questions it aims to answer are:
Read more
What is the ReceptIVFity profile (low, medium, or high) of the vaginal microbiome in these women? How do the endometrial-derived lymphocytes respond to different immune stimuli and microbiota? Can the endometrial stromal cells decidualize effectively in the presence or absence of specific microbiota?
Participants will:
Self-perform a vaginal swab to determine the ReceptIVFity profile of their vaginal microbiome.
Self-collect menstrual blood during 24 hours in 2 blocks of 12 hours for immunological analysis.
- Being tested
- Vaginal microbiome swab, Menstrual Blood Collection via Menstrual Cup
- Keywords
- IVF success prediction, Vaginal microbiome, Menstrual blood immunology, Assisted reproductive technology (ART), Infertility biomarkers
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal microbiome swabDevice
All swabs were collected using FLOQSwabs™ (Copan Italia SpA, Brescia, Italy). The patients were instructed to spread the labia with one hand, insert the swab 3-5 cm beyond the vaginal orifice with the other hand, and rotate the swab along the vaginal wall for 10-15 seconds.
Menstrual Blood Collection via Menstrual CupDevice
Self-collect menstrual blood during 24 hours in 2 blocks of 12 hours
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune Cell Phenotype and Function in Menstrual Blood Stratified by Vaginal Microbiome in IVF Patients
Analysis of monocyte, Natural Killer (NK) cell, T lymphocytes, regulatory T lymphocytes, and T helper cell phenotypes in menstrual blood. Immune responses, including cytokine production and immune marker regulation, will be quantified.
Unit of Measure: Percentage of cell type, cytokine concentrations in pg/mL.
Measured: Baseline and 3 months
Genotyping of Maternal KIR and HLA-C
Determination of maternal Killer cell immunoglobulin-like receptor (KIR) and Major Histocompatibility Complex (HLA-C) genotypes.
Unit of Measure: Genotype classification.
Measured: Baseline
RNA Analysis of Stromal Fibroblast Cells
Analysis of RNA from stromal fibroblast cells to determine expression of tissue adaptation markers (pre-decidualization).
Gene expression levels (e.g., fold change, normalized counts).
Measured: Baseline
Secondary outcomes (1)
Metabolite Analysis as Immune Signaling Modulators in IVF Patients
Analysis of host- and microbiome-derived metabolites serving as signaling molecules that regulate immune function.
Unit of Measure: Metabolite concentrations (µmol/L).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start6 Sep 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility (IVF Patients)Studies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sam Schoenmakers, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709976
- Sponsor's protocol ID
- OZBS72.19236
- Acronym
- R-IMinART
- Status last verified
- Sep 2024
- First submitted
- 26 Nov 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing the Accuracy to Predict Pregnancy Success After Assisted Reproductive Therapy (ART) by Combining the ReceptIVFIty Test with Immunological Parameters
- ClinicalTrials.gov ID
- NCT06709976
- Acronym / sponsor ID
- R-IMinART / OZBS72.19236
- Keywords
- IVF success prediction, Vaginal microbiome, Menstrual blood immunology, Assisted reproductive technology (ART), Infertility biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 29 Nov 2024 (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 goal of this clinical non-invasive observational pilot study is to improve the prediction of pregnancy success after In Vitro Fertilisation (IVF)/IVF -Intracytoplasmic Sperm Injection (ICSI) treatment by examining the vaginal microbiome and the immunological profile of menstrual blood in women (18-42) years old) undergoing their first IVF/IVF/ICSI treatment.
The main questions it aims to answer are:
What is the ReceptIVFity profile (low, medium, or high) of the vaginal microbiome in these women? How do the endometrial-derived lymphocytes respond to different immune stimuli and microbiota? Can the endometrial stromal cells decidualize effectively in the presence or absence of specific microbiota?
Participants will:
Self-perform a vaginal swab to determine the ReceptIVFity profile of their vaginal microbiome.
Self-collect menstrual blood during 24 hours in 2 blocks of 12 hours for immunological analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women aged 18-42 expected to undergo their first IVF/IVF-ICSI cycle within the next two months. The routine IVF/IVF-ICSI procedure will occur irrespective of their participation or the test outcomes.
Key inclusion criteria (5 listed)
- Indication for an IVF or IVF/ICSI procedure.
- 18 years - 42 years.
- European origin
- Willing to provide a vaginal swab with the ReceptIVFity-test.
- Willing to provide informed consent.
Key exclusion criteria (6 listed)
- No transferable embryos after IVF or IVF/ICSI.
- Emergency IVF for cancer or other reasons.
- Women with endometriosis pre-treated with an Gn-RH analogue.
- The use of (hormonal) contraceptives or antibiotics 3 months prior to start IVF or IVF/ICSI.
- Women unable or unwilling to agree with the procedures.
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 |
|---|---|---|
| Vaginal microbiome swabAll swabs were collected using FLOQSwabs™ (Copan Italia SpA, Brescia, Italy). The patients were instructed to spread the labia with one hand, insert the swab 3-5 cm beyond the vaginal orifice with the other hand, and rotate the swab along the vaginal wall for 10-15 seconds. | Device | – |
| Menstrual Blood Collection via Menstrual CupSelf-collect menstrual blood during 24 hours in 2 blocks of 12 hours | Device | – |
Primary outcome
Immune Cell Phenotype and Function in Menstrual Blood Stratified by Vaginal Microbiome in IVF Patients
Time frame: Baseline and 3 months
Analysis of monocyte, Natural Killer (NK) cell, T lymphocytes, regulatory T lymphocytes, and T helper cell phenotypes in menstrual blood. Immune responses, including cytokine production and immune marker regulation, will be quantified. Unit of Measure: Percentage of cell type, cytokine concentrations in pg/mL.
Genotyping of Maternal KIR and HLA-C
Time frame: Baseline
Determination of maternal Killer cell immunoglobulin-like receptor (KIR) and Major Histocompatibility Complex (HLA-C) genotypes. Unit of Measure: Genotype classification.
RNA Analysis of Stromal Fibroblast Cells
Time frame: Baseline
Analysis of RNA from stromal fibroblast cells to determine expression of tissue adaptation markers (pre-decidualization). Gene expression levels (e.g., fold change, normalized counts).
1 secondary outcome
Metabolite Analysis as Immune Signaling Modulators in IVF Patients
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Infertility (IVF Patients)
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
Recruiting
225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women
Infertility (IVF Patients), Infertility Assisted Reproductive Technology
Recruiting
The Effects of Carnitine Supplementation on Oocytes in Women Undergoing IVF Process
Infertility (IVF Patients)
Not yet recruiting
Intra-ovarian CAPA-IVM vs Standard IVM
Infertility (IVF Patients), Infertility
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?
An observational study of Infertility (IVF Patients) and Infertility Assisted Reproductive Technology, run by Erasmus Medical Center at 1 site in Netherlands.
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 6 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 9 Dec 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 Netherlands. 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?
Results are not available in the source record.
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?
Immune Cell Phenotype and Function in Menstrual Blood Stratified by Vaginal Microbiome in IVF Patients (time frame: Baseline and 3 months). The study lists 3 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 9 Dec 2024.