UnknownNot Applicable

Maternal KIR and Fetal HLA Influence Reproductive Success in ART-oocyte Donor.

Spain400 participantsStarted 2022-11-01

Plain-language summary

The present project is an ambispective study designed to answer how HLA-F SNPs, as well as KIR-HLA-C compatibility, influence reproductive outcomes in oocyte donation cycles. On the one hand, healthy patients without history of RIF and RM and with indication of egg donation cycle as ART treatment will be genotype for KIR, HLA-C and HLA-F. HLA-C from male partners and egg donors will be also analyzed. No matching based on HLA-C genotypes would be performed and donors would be assigned to recipients following the routine clinical practices. After SET, patients will be followed up until delivery or until the end of treatment. On the other hand, access to data from patients who have equally undergone oocyte-donation cycles, who meet the inclusion criteria and who have been genotyped for KIR and HLA-C as a matter of routine practice, will be requested. For this study, only the first SET of oocyte-donation that patients undergo will be considered. LBR will be the primary endpoint of the study. In addition, secondary endpoints such as embryo development, sustained implantation, progesterone levels, implantation failure, miscarriage rate and unwanted events (preeclampsia, fetal grow restriction, premature birth, low birth weight…) will also be evaluated.

Who can participate

Age range18 Years – 45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients who have undergone or are undergoing their first egg donation cycle. * Between 18 and 45 years of age. * BMI between 19 and 25 kg/m2 * Signed written informed consent submitted. * No history of RIF, defined as implantation failure after 4 consecutive blastocysts are transferred. * No history of RM, defined as the presence of 2 or more clinical miscarriages. * Normal blood pressure and viral serology. Exclusion Criteria: * Male partner diagnosed with severe male factor * Patients who test positive for thrombophilic disorders (factor V Leiden, prothrombinG20210A mutation, positive antiphospholipid antibodies) * Participation in a different study or clinical trial with a research drug or device in the last three months prior to recruitment. * Known abnormal karyotype of subject or of her partner * Any known clinically significant systemic disease * Known inherited or acquired thrombophilia disease. * Any known endocrine or metabolic abnormalities with the exception of controlled thyroid function disease. * Severe psychiatric conditions. * Patients with uterine factor/abnormalities (eg. myomas, polyps, adenomyosis, etc), that determines an unsatisfactory ultrasound for their ART. * Patients with PCOS. * Patients diagnosed with autoimmune diseases (eg. Systemic Lupus erythematosus, multiple sclerosis, rheumatoid arthritis). * Patients with recent diagnosis (6 months) of chronic infectious disease (HPV, HBV, HCV, HIV, TBC). * Patients with current …

What they're measuring

To determine if certain combinations of maternal KIR and oocyte donor HLA-C genotypes results in improved outcomes of live birth rate.

Timeframe: 36 months

Trial details

NCT IDNCT05606679

SponsorIVI Madrid

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-01

Contact for this trial

Diana Alecsandru, PhD

+34 91 180 29 00 Diana.Alecsandru@ivirma.com