PREDICTIVE IMMUNOLOGICAL STUDY OF RECURRENT ABORTIONS AND IMPLANTATION FAILURE

Completed

• Conditions: Maternal-Fetal KIR-HLA-C Compatibility

• 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).

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Status Verified: 2019-08
• Study First Submitted: 2019-08-08
• Study First Submitted QC: 2019-08-08
• Study First Posted: 2019-08-09
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal genetic compatibility profile fetal KIR-HLA-C	2 years	KIR AA, KIR AB, KIR BB