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NCT02718105 Clinical Trial

Maternal and Fetal Compatibility in Assisted Reproductive Technology (ART)-Oocyte Donor Influences Live Birth Rate

Infertility Clinical Trial

Official title:
Maternal Killer Cell Immunoglobulin-like Receptors (KIR) and Fetal (Human Leukocyte Antigen) HLA-C Compatibility in ART-oocyte Donor Influences Live Birth Rate a Prospective Controlled Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02718105
Other study ID # 1512-MAD-067-JG
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date August 1, 2022

Study information
Verified date August 2022
Source IVI Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Has the maternal KIR haplotype an impact in pregnancy, miscarriage and live birth rates per embryo transfer in donor oocytes -ART by paternal and oocyte donor HLA-C?

Description:

The combination of maternal KIR haplotype and parental, donors HLA-C, could predict which couple can benefit for the selection of single embryo transfer (SET)/double embryo transfer (DET), or donor selection by HLA-C in ART, in order to increase the live birth rate (LBR)/cycle since HLA-C1/C1 donors are predicted to be safer and C2/C2 males or oocyte donors may be mor "dangerous" as identified by epidemiological studies

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date August 1, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - BMI between 19 - 27 kg/m2 - Blastocyst embryo transfer previous. - Normal karyotype, thrombophylic and immunological results. - Normal clinical history, viral serology, hormonal analysis (TSH, T4, prolactin, estrogen, progesterone), spermiogram, sperm FISH and pelvic ultrasound results. Exclusion Criteria: - Pregnancy women. - Psychiatric disorders. - Uterus alterations. - Polycystic ovary syndrome - Genetic and autoimmune diseases. - Infectious diseases. - Corticoid and immunosuppressant treatments previous.

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• KIR HLAC determinations
We will take blood samples for KIR HLA-C determinations.

Locations
Country Name City State
Spain Instituto Valenciano de Infertilidad Madrid

Sponsors (1)
Lead Sponsor Collaborator
IVI Madrid

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Compatibility maternal fetal KIR HLA-C KIR haplotype regions will be defined by the presence of the following KIR genes: Cen-A/2DL3: Tel-A/3DL1 and 2DS4; Cen-B/2DL2 and 2DS2; Tel-B/2DS1 and 3DS1. The HLA-C ligands for KIRs will be divided into 2 groups: HLA-C1 and HLA_C2 2 years
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