Maternal-Fetal KIR-HLA-C Compatibility Clinical Trial
Official title:
Predictive Inmunological Study to Assess the Rate of Gestation, Abortion and Live Newborn in Patients With Recurrent Abortions and Recurrent Implantation Failure.
| NCT number | NCT04052438 |
| Other study ID # | 1405-MAD-026-JG |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2015 |
| Est. completion date | January 2017 |
| Verified date | August 2019 |
| Source | IVI Madrid |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | January 2017 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
Inclusion Criteria in recurrent implantation failure: - 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 - 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. Exclusion Criteria: - 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...) - 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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| IVI Madrid |
Adams EJ, Parham P. Species-specific evolution of MHC class I genes in the higher primates. Immunol Rev. 2001 Oct;183:41-64. Review. — View Citation
Apps 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 antibodie — View Citation
Arck 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. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maternal genetic compatibility profile fetal KIR-HLA-C | KIR AA, KIR AB, KIR BB | 2 years |