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

NCT05606679 | Unknown

• 1 other identifier: 2207-MAD-098-DA
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Reproductive Issues

Outcome Measures

Primary Outcomes (1)

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

  Principally, to establish whether patients of KIR AA and KIR Bx (2DS1-) genotypes show better outcomes when receiving oocytes from HLA-C1C1 donors than from donors with at least one HLA-C2 allele.

  36 months

Secondary Outcomes (1)

• To determine if certain combinations of maternal KIR and oocyte donor HLA-C genotypes results in improved outcomes of live birth rate taking into account the extra HLA-C2 alleles of the embryo.

  36 months

Study Arms (1)

Patients undergoing ART with oocyte donation

Healthy patients with no history of RIF and RM which have undergone or are undergoing ART with oocyte donation and SET.

Genetic: Analysis combinations of maternal KIR and HLA-C genotypes

Interventions

Analysis combinations of maternal KIR and HLA-C genotypes GENETIC

Analysis of combinations of maternal KIR and HLA-C genotypes of the egg donor and fetus (based on the genotypes of the donor and male partner), as well as different HLA-F SNP genotypes of the recipients

Patients undergoing ART with oocyte donation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of healthy patients with no history of RIF and RM which have undergone or are undergoing ART with oocyte donation and SET at IVI RMA Madrid, Valencia y Barcelona. Study subject candidates will be informed about the study once the inclusion criteria have been met. Data on reproductive outcomes, embryo development and perinatal and obstetric complications will be collected.

You may qualify if:

• 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.

You may not qualify if:

• 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 treatment of immunosuppressant (eg. corticosteroids, monoclonal antibodies…).

Sponsors & Collaborators

• IVI Madrid: lead
• Diana Alecsandru: collaborator

Study Sites (1)

Instituto Valenciano de Infertilidad

Madrid, 28035, Spain

RECRUITING

Study Officials

• Juan Antonio Garcia Velasco, PhD

  IVIRMA MADRID

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Alecsandru, PhD

CONTACT

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

Juan Antonio Garcia Velasco, PhD

CONTACT

+34 91 180 29 00; juan.garcia.velasco@ivirma.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 7, 2022
• Study Start: November 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2025
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)