NCT02718105

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
5.8 years until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

March 11, 2016

Last Update Submit

August 9, 2022

Conditions

Keywords

KIR HLA-CART

Outcome Measures

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

    2 years

Study Arms (1)

Receiver patients in donor oocyte -ART

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

Genetic: KIR HLAC determinations

Interventions

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

Receiver patients in donor oocyte -ART

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing an assisted reproductive treatment

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Valenciano de Infertilidad

Madrid, 28035, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Genomic DNA will be obtained and will be studied in Professor Moffet laboratory in Cambridge (department of Pathologí, University of Cambridge) KIR typing including copi number and HLA-C loci will be performed as previously described (Hiby 2010, Jiang 2012). 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.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Juan Antonio Garcia Velasco, PhD

    IVI Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 11, 2016

First Posted

March 24, 2016

Study Start

January 1, 2022

Primary Completion

April 1, 2022

Study Completion

August 1, 2022

Last Updated

August 11, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations