How maternal and fetal genetic factors affect success in egg donation cycles
Maternal KIR and Fetal HLA Influence Reproductive Success in ART-oocyte Donor.
This study is testing how the genes of mothers and babies affect the success of egg donation cycles for women having their first attempt.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | IVI Madrid Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT05606679 on ClinicalTrials.gov |
What this trial studies
This ambispective study investigates the influence of maternal KIR and fetal HLA genotypes on reproductive outcomes in women undergoing their first egg donation cycle. Healthy patients without a history of reproductive failure will be genotyped for KIR, HLA-C, and HLA-F, while male partners and egg donors will also be analyzed for their HLA-C alleles. Patients will undergo a single embryo transfer (SET) and will be monitored until delivery or the end of treatment, with various reproductive outcomes assessed, including live birth rate and complications. Additionally, data from past patients who meet the criteria will be analyzed to enhance the study's findings.
Who should consider this trial
Good fit: Ideal candidates are healthy women aged 18 to 45 who are undergoing their first egg donation cycle and have no history of reproductive failure.
Not a fit: Patients with severe male factor infertility or those with certain thrombophilic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding of genetic factors influencing reproductive success, potentially leading to better outcomes for patients undergoing egg donation.
How similar studies have performed: While the specific genetic combinations being studied may be novel, previous studies have shown that genetic compatibility can influence reproductive outcomes in assisted reproductive technology.
Eligibility criteria
Show full inclusion / exclusion criteria
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 treatment of immunosuppressant (eg. corticosteroids, monoclonal antibodies...).
Where this trial is running
Madrid
- Instituto Valenciano de Infertilidad — Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Juan Antonio Garcia Velasco, PhD — Ivirma Madrid
- Study coordinator: Diana Alecsandru, PhD
- Email: Diana.Alecsandru@ivirma.com
- Phone: +34 91 180 29 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.