ClinicalTrials.gg
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

In context

Infertility

2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.

This study's enrollment of 200 is close to the median of 200 across 592 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

IVI Madrid is the lead sponsor of 35 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 diseases.
  • Infectious diseases.
  • Corticoid and treatments previous.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

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.

06

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

07

Study locations

1 site
  • Instituto Valenciano de Infertilidad
    Madrid, 28035, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2022 to primary completion in Apr 2022, 3 months.

Of 209 non-industry observational studies under Infertility, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 100. This study's 3 months is below that.

Counting every sponsor, half of 242 studies reached it within 39 months; a quarter within 16 and three quarters within 100.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 11, 2016
First posted
Mar 24, 2016
StartActual
Jan 1, 2022
Primary completionActual
Apr 1, 2022
CompletionActual
Aug 1, 2022
Last update
Aug 11, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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