Immunomodulatory DrugsNCT06264206
Effect of Immunomodulatory Treatment on IVF (in Vitro Fertilization) Outcomes in Patients With KIR AA Genotype
A study testing Killer-cell immunoglobulin-like receptors (KIRs) testing in people with Immunomodulatory Drugs and Killer-cell Immunoglobulin-like Receptors (KIRs), run by Calla IVF Center at 1 site in Romania.
Trial summary
The aim of the study is to investigate the immune cause of recurrent implantation failure (RIF) and the role of immunomodulatory treatment in IVF (in vitro fertilization) patients that have a KIR AA genotype. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Immunomodulatory Drugs, Killer-cell Immunoglobulin-like Receptors (KIRs), KIR Alleles (KIR AA)
- What is being tested?
- Killer-cell immunoglobulin-like receptors (KIRs) testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jan 2022to 31 Dec 2023
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with an infertility diagnosis having an IVF procedure with at least two top-quality embryo to transfer (according to Gardners criteria)
- patients that sign the accord to be enrolled in this study
- patients with a negative test for chronic endometritis and normal hysteroscopic findings,
- patients that have an history of recurrent pregnancy loss and have an IVF indication will be tested in the first round.
Who cannot join
- absence of signed consent
- refusal of hysteroscopy
- uterine abnormalities
- thin endometrium
- endometrial polyps
- pelvic cancer
Show all 9Show fewer
- acute inflammatory disease
- Asherman syndrome
- chronic endometritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Immunomodulatory Treatment on IVF Outcomes in Patients With KIRR AA Genotype: a Retrospective Cohort Study With Implications for Personalized Fertility Strategies
The aim of the study is to investigate the immune cause of recurrent implantation failure (RIF) and the role of immunomodulatory treatment in IVF (in vitro fertilization) patients that have a KIR AA genotype. We compared pregnancy rates in Group KIR AA without immunomodulatory treatment, and pregnancy rates in Group KIR AA with immunomodulatory treatment.
Read the detailed description
The investigators included patients that underwent an (IVF )in vitro fertilization procedure in CALLA IVF Clinic Oradea - Romania, between 01 January 2022 and 31 December 2023.
Recurrent implantation failure (RIF) impacts 10% of couples undergoing in vitro fertilization (IVF), prompting the exploration of tailored treatments to address underlying causes and enhance implantation rates. Among these causes, maternal immune tolerance toward embryos has garnered significant attention in RIF research, with Killer-cell immunoglobulin-like receptors (KIRs) on natural killer (NK) cells emerging as key players in maternal-fetal immune interactions. The investigation into KIR alleles (KIR AA) in RIF is rooted in the theory that specific KIR-HLA-C combinations may contribute to implantation failures. Recent studies suggest that KIR genotyping could serve as a predictive tool for RIF, potentially enabling personalized approaches in assisted reproductive technology, such as immunomodulatory treatments and tailored embryo transfers.
All couples underwent IVF ovarian stimulation, with various factors documented including age, type of infertility, number of oocytes retrieved, number of embryos produced, pregnancy rate.
A total of 65 patients were enrolled in this study, with 24 patients included in group A, this is the group with KIR AA and 41 patients included in the group B, meaning the group with the KIR Bx Inclusion criteria: patients with an infertility diagnosis having an IVF procedure with at least two top-quality embryo to transfer (according to Gardners criteria), that sign the accord to be enrolled in this study with a negative test for chronic endometritis and normal hysteroscopic findings, also patients that have an history of recurrent pregnancy loss and have an IVF indication will be tested in the first round.
Exclusion criteria: absence of signed consent, refusal of hysteroscopy, uterine abnormalities, thin endometrium, endometrial polyps, pelvic cancer, acute inflammatory disease, Asherman syndrome, chronic endometritis, oocyte or spermatozoa donor.
The KIR AA group experienced improved pregnancy outcomes compared to those in the same cohort who did not undergo prior immunomodulatory treatment
- Conditions
- Immunomodulatory Drugs, Killer-cell Immunoglobulin-like Receptors (KIRs), KIR Alleles (KIR AA)
- Being tested
- Killer-cell immunoglobulin-like receptors (KIRs) testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Killer-cell immunoglobulin-like receptors (KIRs) testingDiagnostic test
Also called immunomodulatory treatment for KIR AA
patients were tested for KIRs, and based on the divided in the 2 arms. Patient from ARM KIR AA received immunomuodulatorc treatment.
| Study group | Role | What they receive |
|---|---|---|
| KIR AA | Experimental | Patients from arm KIR AA received immunomodulatory treatment, and the pregnancy rate was calculated after this treatment, and compared to the one before the treatment Receives: Diagnostic Test: Killer-cell immunoglobulin-like receptors (KIRs) testing |
| KIR BX | No intervention | Patients from arm KIR BX did not receive immunomodulatory treatment, and the pregnancy rate was calculated and compared with the ones from arm KIRR AA- before and after immunomodulatory treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of immune cause of recurrent implantation failure
Measured: 3-6 months
the efficiency of immnomodulatory treatment on pregnancy rate in patients with KIR AA
Measured: 3-6 months
Secondary outcomes (1)
comparation between the pregnancy rates in KIR AA group and KIR Bx group
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunomodulatory DrugsStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calla IVF Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264206
- Sponsor's protocol ID
- CALLA_IVF_KIR
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Immunomodulatory Treatment on IVF Outcomes in Patients With KIRR AA Genotype: a Retrospective Cohort Study With Implications for Personalized Fertility Strategies
- ClinicalTrials.gov ID
- NCT06264206
- Acronym / sponsor ID
- CALLA_IVF_KIR
- Conditions
- Immunomodulatory Drugs, Killer-cell Immunoglobulin-like Receptors (KIRs), KIR Alleles (KIR AA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Calla IVF CenterUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 16 Feb 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 aim of the study is to investigate the immune cause of recurrent implantation failure (RIF) and the role of immunomodulatory treatment in IVF (in vitro fertilization) patients that have a KIR AA genotype. We compared pregnancy rates in Group KIR AA without immunomodulatory treatment, and pregnancy rates in Group KIR AA with immunomodulatory treatment.
Detailed description
The investigators included patients that underwent an (IVF )in vitro fertilization procedure in CALLA IVF Clinic Oradea - Romania, between 01 January 2022 and 31 December 2023.
Recurrent implantation failure (RIF) impacts 10% of couples undergoing in vitro fertilization (IVF), prompting the exploration of tailored treatments to address underlying causes and enhance implantation rates. Among these causes, maternal immune tolerance toward embryos has garnered significant attention in RIF research, with Killer-cell immunoglobulin-like receptors (KIRs) on natural killer (NK) cells emerging as key players in maternal-fetal immune interactions. The investigation into KIR alleles (KIR AA) in RIF is rooted in the theory that specific KIR-HLA-C combinations may contribute to implantation failures. Recent studies suggest that KIR genotyping could serve as a predictive tool for RIF, potentially enabling personalized approaches in assisted reproductive technology, such as immunomodulatory treatments and tailored embryo transfers.
All couples underwent IVF ovarian stimulation, with various factors documented including age, type of infertility, number of oocytes retrieved, number of embryos produced, pregnancy rate.
A total of 65 patients were enrolled in this study, with 24 patients included in group A, this is the group with KIR AA and 41 patients included in the group B, meaning the group with the KIR Bx Inclusion criteria: patients with an infertility diagnosis having an IVF procedure with at least two top-quality embryo to transfer (according to Gardners criteria), that sign the accord to be enrolled in this study with a negative test for chronic endometritis and normal hysteroscopic findings, also patients that have an history of recurrent pregnancy loss and have an IVF indication will be tested in the first round.
Exclusion criteria: absence of signed consent, refusal of hysteroscopy, uterine abnormalities, thin endometrium, endometrial polyps, pelvic cancer, acute inflammatory disease, Asherman syndrome, chronic endometritis, oocyte or spermatozoa donor.
The KIR AA group experienced improved pregnancy outcomes compared to those in the same cohort who did not undergo prior immunomodulatory treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KIR AA | Experimental | Diagnostic Test: Killer-cell immunoglobulin-like receptors (KIRs) testingPatients from arm KIR AA received immunomodulatory treatment, and the pregnancy rate was calculated after this treatment, and compared to the one before the treatment |
| KIR BX | No intervention | –Patients from arm KIR BX did not receive immunomodulatory treatment, and the pregnancy rate was calculated and compared with the ones from arm KIRR AA- before and after immunomodulatory treatment |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients with an infertility diagnosis having an IVF procedure with at least two top-quality embryo to transfer (according to Gardners criteria)
- patients that sign the accord to be enrolled in this study
- patients with a negative test for chronic endometritis and normal hysteroscopic findings,
- patients that have an history of recurrent pregnancy loss and have an IVF indication will be tested in the first round.
Key exclusion criteria (9 listed)
- absence of signed consent
- refusal of hysteroscopy
- uterine abnormalities
- thin endometrium
- endometrial polyps
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 |
|---|---|---|
| Killer-cell immunoglobulin-like receptors (KIRs) testingAlso: immunomodulatory treatment for KIR AApatients were tested for KIRs, and based on the divided in the 2 arms. Patient from ARM KIR AA received immunomuodulatorc treatment. | Diagnostic test | KIR AA |
Primary outcome
the incidence of immune cause of recurrent implantation failure
Time frame: 3-6 months
the efficiency of immnomodulatory treatment on pregnancy rate in patients with KIR AA
Time frame: 3-6 months
1 secondary outcome
comparation between the pregnancy rates in KIR AA group and KIR Bx group
Time frame: 3-6 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 16 Feb 2024.
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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 Killer-cell immunoglobulin-like receptors (KIRs) testing in people with Immunomodulatory Drugs and Killer-cell Immunoglobulin-like Receptors (KIRs), run by Calla IVF Center at 1 site in Romania.
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 4 inclusion and 9 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 16 Feb 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 Romania. 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?
the incidence of immune cause of recurrent implantation failure (time frame: 3-6 months). 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 16 Feb 2024.