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

Completed

• Conditions: Infertility
• Interventions: Genetic: KIR HLAC determinations

• Registration Number: NCT02718105
• Lead Sponsor: IVI Madrid

Brief 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?

Detailed 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

Study Timeline

• Study First Submitted: 2016-03-11
• Study First Submitted QC: 2016-03-22
• Study First Posted: 2016-03-24
• Study Start: 2022-01-01
• Primary Completion: 2022-04-01
• Status Verified: 2022-08
• Study Completion: 2022-08-01
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

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

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Receiver patients in donor oocyte -ART	KIR HLAC determinations	Maternal and fetal compatibility KIR HLA-C determinations in ART -oocyte donor

Primary Outcome Measures

Name	Time	Method
Compatibility maternal fetal KIR HLA-C	2 years	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

Trial Locations

Locations (1)

Instituto Valenciano de Infertilidad; 🇪🇸 Madrid, Spain