Maternal-Fetal KIR-HLA-C CompatibilityNCT04052438
PREDICTIVE IMMUNOLOGICAL STUDY OF RECURRENT ABORTIONS AND IMPLANTATION FAILURE
An observational study of Maternal-Fetal KIR-HLA-C Compatibility, run by IVI Madrid.
Trial summary
The involvement of the immune system in the process of implantation and its modulation as a therapeutic line in these alterations, failure of implantation and repetition abortion are controversial and make it necessary to conduct clinical studies properly led and with a study population chosen by strict criteria in… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Maternal-Fetal KIR-HLA-C Compatibility
- What is being tested?
- HLA-C and KIR determination for patients, couples, oocyte or semen donors, abortive tissue and newborn.
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2017
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with a history of recurrent abortion (more than 3 idiopathic involuntary abortions) or recurrent implantation failure (more than 3 failures of IVF cycles with good quality embryos or more 2 failures in cycles with donor eggs) that will undergo a cycle assisted reproduction
Who may be able to join
- Body mass index between 19 and 27 kg/m2
- Patients with 3 or more IVF failures following transfer of good quality embryos or with 2 or more failures following embryo transfer in egg donation cycles.
- At least one embryo transfer is required to have been made in a blastocyst state (embryo on day 5) and with the current partner/donor.
- Study of normal karitype..
- Normal thrombophilia study.
- Vaginal exudate (Chlamydia, ureaplasma) normal
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- Normal immune study.
- No hormone treatment in the two months prior to inclusion in the study.
- Inclusión criteria in recurrent abortion:
- Body mass index between 19 and 27 kg/m2
- Patients with 3 or more recurrent abortions, natural gestations or after transfer of good quality embryos (own or ovodonation)
- Study of normal karitype.
- Normal thrombophilia study.
- Vaginal exudate (Chlamydia, ureaplasma) normal
- Normal immune study.
- No hormone treatment in the two months prior to inclusion in the study.
Who cannot join
- Pregnant or lactating women.
- They cannot offer cooperation.
- Participation in a study or clinical trial during the 3 months prior to inclusion.
- Patients with fibromes.
- Patients with PCOS.
- Patients with some genetic alteration (altered karitype, cystic fibrosis, multiple sclerosis, rheumatoid arthritis...)
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- Patients chronic infectious disease.
- Patients in maintenance treatment with immunosuppressants.
- Patients who have received systemic corticosteroids in the last 4 weeks.
- Patients diagnosed with chronic lymphoproliferative disease.
About this study
Official title: Predictive Inmunological Study to Assess the Rate of Gestation, Abortion and Live Newborn in Patients With Recurrent Abortions and Recurrent Implantation Failure.
The involvement of the immune system in the process of implantation and its modulation as a therapeutic line in these alterations, failure of implantation and repetition abortion are controversial and make it necessary to conduct clinical studies properly led and with a study population chosen by strict criteria in order to better understand the involvement of the different innate and adaptive immune mechanisms in the field of reproductive medicine and especially in clinically expressed failures recurrent implantation failure and recurrent abortions.
Read the detailed description
A prospective pilot study is proposed in patients with recurrent implantation failure and recurrent abortions undergoing assisted reproductive techniques.
The main objective of this study is to determine the involvement of key effectors of innate immune response in the endometrium that induces a pro-inflammatory response, and to be able to know in particular what is the distribution of KIR receptors in the uNK and the HLA-C typing in patient-mother, egg/semen donors, male-father, abortive remains, live newborns.
To this end, the distribution of KIR and HLA-C receptors will be studied two arms/patient groups, divided from a population chosen according to inclusion/exclusion criteria:
- Group I: group recurrent abortions.
- Group II: group recurrent implementation failure. The study population will include subjects of older age (aged between 18 and 37 years) who will be divided into 2 total Study Arms N x 200 (n x 100 for each arm).
- Conditions
- Maternal-Fetal KIR-HLA-C Compatibility
- Being tested
- HLA-C and KIR determination for patients, couples, oocyte or semen donors, abortive tissue and newborn.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLA-C and KIR determination for patients, couples, oocyte or semen donors, abortive tissue and newborn.Diagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Patients with recurrent abortion. | More than three idiopathic involuntary miscarriages. Receives: Diagnostic Test: HLA-C and KIR determination for patients, couples, oocyte or semen donors, abortive tissue and newborn. | |
| Patients with implantation failure. | More than three IVF abortions with good quality embryos or more than two abortions in oocyte donation cycles. Receives: Diagnostic Test: HLA-C and KIR determination for patients, couples, oocyte or semen donors, abortive tissue and newborn. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal genetic compatibility profile fetal KIR-HLA-C
KIR AA, KIR AB, KIR BB
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study startJan 2015
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Maternal-Fetal KIR-HLA-C CompatibilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana Alecsandru, Principal investigator, IVI Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052438
- Sponsor's protocol ID
- 1405-MAD-026-JG
- Status last verified
- Aug 2019
- First submitted
- 8 Aug 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adams EJ, Parham P. Species-specific evolution of MHC class I genes in the higher primates. Immunol Rev. 2001 Oct;183:41-64. doi: 10.1034/j.1600-065x.2001.1830104.x.
PubMed 11782246Apps R, Murphy SP, Fernando R, Gardner L, Ahad T, Moffett A. Human leucocyte antigen (HLA) expression of primary trophoblast cells and placental cell lines, determined using single antigen beads to characterize allotype specificities of anti-HLA antibodies. Immunology. 2009 May;127(1):26-39. doi: 10.1111/j.1365-2567.2008.03019.x.
PubMed 19368562Arck PC, Hecher K. Fetomaternal immune cross-talk and its consequences for maternal and offspring's health. Nat Med. 2013 May;19(5):548-56. doi: 10.1038/nm.3160. Epub 2013 May 7.
PubMed 23652115Alecsandru D, Barrio A, Garrido N, Aparicio P, Pellicer A, Moffett A, Garcia-Velasco JA. Parental human leukocyte antigen-C allotypes are predictive of live birth rate and risk of poor placentation in assisted reproductive treatment. Fertil Steril. 2020 Oct;114(4):809-817. doi: 10.1016/j.fertnstert.2020.05.008. Epub 2020 Jul 31.
PubMed 32741616
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Inmunological Study to Assess the Rate of Gestation, Abortion and Live Newborn in Patients With Recurrent Abortions and Recurrent Implantation Failure.
- ClinicalTrials.gov ID
- NCT04052438
- Acronym / sponsor ID
- 1405-MAD-026-JG
- Conditions
- Maternal-Fetal KIR-HLA-C Compatibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 9 Aug 2019 (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 involvement of the immune system in the process of implantation and its modulation as a therapeutic line in these alterations, failure of implantation and repetition abortion are controversial and make it necessary to conduct clinical studies properly led and with a study population chosen by strict criteria in order to better understand the involvement of the different innate and adaptive immune mechanisms in the field of reproductive medicine and especially in clinically expressed failures recurrent implantation failure and recurrent abortions.
Detailed description
A prospective pilot study is proposed in patients with recurrent implantation failure and recurrent abortions undergoing assisted reproductive techniques.
The main objective of this study is to determine the involvement of key effectors of innate immune response in the endometrium that induces a pro-inflammatory response, and to be able to know in particular what is the distribution of KIR receptors in the uNK and the HLA-C typing in patient-mother, egg/semen donors, male-father, abortive remains, live newborns.
To this end, the distribution of KIR and HLA-C receptors will be studied two arms/patient groups, divided from a population chosen according to inclusion/exclusion criteria:
- Group I: group recurrent abortions.
- Group II: group recurrent implementation failure. The study population will include subjects of older age (aged between 18 and 37 years) who will be divided into 2 total Study Arms N x 200 (n x 100 for each arm).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with recurrent abortion. | – | Diagnostic Test: HLA-C and KIR determination for patients, couples, oocyte or semen donors, abortive tissue and newborn.More than three idiopathic involuntary miscarriages. |
| Patients with implantation failure. | – | Diagnostic Test: HLA-C and KIR determination for patients, couples, oocyte or semen donors, abortive tissue and newborn.More than three IVF abortions with good quality embryos or more than two abortions in oocyte donation cycles. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with a history of recurrent abortion (more than 3 idiopathic involuntary abortions) or recurrent implantation failure (more than 3 failures of IVF cycles with good quality embryos or more 2 failures in cycles with donor eggs) that will undergo a cycle assisted reproduction
Key inclusion criteria (16 listed)
- Body mass index between 19 and 27 kg/m2
- Patients with 3 or more IVF failures following transfer of good quality embryos or with 2 or more failures following embryo transfer in egg donation cycles.
- At least one embryo transfer is required to have been made in a blastocyst state (embryo on day 5) and with the current partner/donor.
- Study of normal karitype..
- Normal thrombophilia study.
Key exclusion criteria (10 listed)
- Pregnant or lactating women.
- They cannot offer cooperation.
- Participation in a study or clinical trial during the 3 months prior to inclusion.
- Patients with fibromes.
- Patients with PCOS.
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 |
|---|---|---|
| HLA-C and KIR determination for patients, couples, oocyte or semen donors, abortive tissue and newborn. | Diagnostic test | Patients with implantation failure., Patients with recurrent abortion. |
Primary outcome
Maternal genetic compatibility profile fetal KIR-HLA-C
Time frame: 2 years
KIR AA, KIR AB, KIR BB
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 21 Aug 2019.
- Results publication: PubMed 11782246Adams EJ, Parham P. Species-specific evolution of MHC class I genes in the higher primates. Immunol Rev. 2001 Oct;183:41-64. doi: 10.1034/j.1600-065x.2001.1830104.x.
- Results publication: PubMed 19368562Apps R, Murphy SP, Fernando R, Gardner L, Ahad T, Moffett A. Human leucocyte antigen (HLA) expression of primary trophoblast cells and placental cell lines, determined using single antigen beads to characterize allotype specificities of anti-HLA antibodies. Immunology. 2009 May;127(1):26-39. doi: 10.1111/j.1365-2567.2008.03019.x.
- Results publication: PubMed 23652115Arck PC, Hecher K. Fetomaternal immune cross-talk and its consequences for maternal and offspring's health. Nat Med. 2013 May;19(5):548-56. doi: 10.1038/nm.3160. Epub 2013 May 7.
- Derived from this study: PubMed 32741616Alecsandru D, Barrio A, Garrido N, Aparicio P, Pellicer A, Moffett A, Garcia-Velasco JA. Parental human leukocyte antigen-C allotypes are predictive of live birth rate and risk of poor placentation in assisted reproductive treatment. Fertil Steril. 2020 Oct;114(4):809-817. doi: 10.1016/j.fertnstert.2020.05.008. Epub 2020 Jul 31.
- Individual participant dataSharing planned: No
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.
Diana Alecsandru principal investigator
IVI Madrid
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal-Fetal KIR-HLA-C Compatibility, run by IVI Madrid.
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 16 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: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Maternal genetic compatibility profile fetal KIR-HLA-C (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04052438, which also lists 4 linked publications.
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 21 Aug 2019.