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CompletedNCT02718105Updated Aug 11, 2022

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

An observational study in Infertility, sponsored by IVI Madrid. Completed at 1 site in Spain. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-11.

Sponsored by IVI Madrid · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 45 Years
Sex
Female
01

Study 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?

Read the 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

02

Conditions studied

  • Infertility

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Keywords

  • KIR HLA-C
  • ART
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients undergoing an assisted reproductive treatment

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

Exclusion Criteria:

  • Pregnancy women.
  • Psychiatric disorders.
  • Uterus alterations.
  • Polycystic ovary syndrome
  • Genetic and autoimmune diseases.
  • Infectious diseases.
  • Corticoid and immunosuppressant treatments previous.
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Receiver patients in donor oocyte -ART

    Maternal and fetal compatibility KIR HLA-C determinations in ART -oocyte donor

    Genetic: KIR HLAC determinations

Interventions

  • GeneticKIR HLAC determinations

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

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 years

06

Study locations

1 site
  • Instituto Valenciano de Infertilidad
    Madrid, 28035, Spain
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT02718105
Lead sponsor
IVI Madrid
Responsible party
Juan A Garcia-Velasco (PhD, IVI Madrid) — Principal investigator
First posted
Mar 24, 2016
Start date
Jan 1, 2022
Primary completion
Apr 1, 2022
Completion
Aug 1, 2022
Last update
Aug 11, 2022

Study contacts

Juan Antonio Garcia Velasco, PhD
principal investigator · IVI Madrid

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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