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NCT Number: NCT02718105

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

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?

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Instituto Valenciano de Infertilidad

Madrid, 28035, Spain

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KIR HLAC determinations

Genetic

We will take blood samples for KIR HLA-C determinations.

Primary outcomes

  1. Compatibility maternal fetal KIR HLA-C

    Time frame: 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

Sponsors and collaborators

Lead sponsor

IVI Madrid

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 24, 2016
Registry last updated
Aug 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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