PREDICTIVE IMMUNOLOGICAL STUDY OF RECURRENT ABORTIONS AND IMPLANTATION FAILURE
- Conditions
- Maternal-Fetal KIR-HLA-C Compatibility
- Interventions
- Diagnostic Test: HLA-C and KIR determination for patients, couples, oocyte or semen donors, abortive tissue and newborn.
- Registration Number
- NCT04052438
- Lead Sponsor
- IVI Madrid
- Brief 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 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 200
Not provided
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with recurrent abortion. 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. 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.
- Primary Outcome Measures
Name Time Method Maternal genetic compatibility profile fetal KIR-HLA-C 2 years KIR AA, KIR AB, KIR BB
- Secondary Outcome Measures
Name Time Method