Reproductive IssuesNCT05606679
Maternal KIR and Fetal HLA Influence Reproductive Success in ART-oocyte Donor.
An observational study of Reproductive Issues, run by IVI Madrid at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Reproductive Issues
- What is being tested?
- Analysis combinations of maternal KIR and HLA-C genotypes
- How many people
- 400 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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…).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Instituto Valenciano de Infertilidad
Madrid, 28035
Juan A Garcia-Velasco, MD, 341802900
Juan A Garcia-Velasco, MD
About this study
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.
Read the detailed description
This is an ambispective study in which healthy patients without history of RIF and RM and with indication of egg donation cycle as ART treatment will be genotyped for KIR, HLA-C and HLA-F. Male partners and egg donors will also be studied for their HLA-C alleles. Patients would be assigned to donors, following routine clinical practice, without matching based on donor's HLA-C genotype. They would undergo SET and be followed up until delivery.
In addition to this prospective part, we will request access to data from patients who have equally undergone oocyte donation cycles at the clinic, who meet the inclusion criteria and who have been genotyped for KIR and HLA-C as a matter of routine practice.
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 (form the prospective part of this proyect) will be correlated with reproductive outcomes. LBR will be the primary endpoint of the study. In addition, secondary endpoints such as embryo development, sustained implantation, progesterone leves, implantation failure and miscarriage rate will also be evaluated. Obstetrical complications such as preeclampsia, premature birth (<34 weeks) and low birth weight will also be evaluated.
- Conditions
- Reproductive Issues
- Being tested
- Analysis combinations of maternal KIR and HLA-C genotypes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis combinations of maternal KIR and HLA-C genotypesGenetic
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: Analysis combinations of maternal KIR and HLA-C genotypes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
To determine if certain combinations of maternal KIR and oocyte donor HLA-C genotypes results in improved outcomes of live birth rathe, in the same way as in the primary target, but taking into account the extra HLA-C2 alleles of the embryo with respect to the mother and the alternative division of the maternal genotypes into KIR AA, AB and BB.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start1 Nov 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IVI Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Diana Alecsandru
- Responsible party
- Sponsor
- Investigators
- Juan Antonio Garcia Velasco, PhD, Principal investigator, IVIRMA MADRID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606679
- Sponsor's protocol ID
- 2207-MAD-098-DA
- Status last verified
- Jan 2024
- First submitted
- 31 Oct 2022
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal KIR and Fetal HLA Influence Reproductive Success in ART-oocyte Donor.
- ClinicalTrials.gov ID
- NCT05606679
- Acronym / sponsor ID
- 2207-MAD-098-DA
- Conditions
- Reproductive Issues
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Collaborators
- Diana Alecsandru
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an ambispective study in which healthy patients without history of RIF and RM and with indication of egg donation cycle as ART treatment will be genotyped for KIR, HLA-C and HLA-F. Male partners and egg donors will also be studied for their HLA-C alleles. Patients would be assigned to donors, following routine clinical practice, without matching based on donor's HLA-C genotype. They would undergo SET and be followed up until delivery.
In addition to this prospective part, we will request access to data from patients who have equally undergone oocyte donation cycles at the clinic, who meet the inclusion criteria and who have been genotyped for KIR and HLA-C as a matter of routine practice.
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 (form the prospective part of this proyect) will be correlated with reproductive outcomes. LBR will be the primary endpoint of the study. In addition, secondary endpoints such as embryo development, sustained implantation, progesterone leves, implantation failure and miscarriage rate will also be evaluated. Obstetrical complications such as preeclampsia, premature birth (<34 weeks) and low birth weight will also be evaluated.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing ART with oocyte donation | – | Genetic: Analysis combinations of maternal KIR and HLA-C genotypesHealthy patients with no history of RIF and RM which have undergone or are undergoing ART with oocyte donation and SET. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis combinations of maternal KIR and HLA-C genotypesAnalysis 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 | Genetic | Patients undergoing ART with oocyte donation |
Primary outcome
To determine if certain combinations of maternal KIR and oocyte donor HLA-C genotypes results in improved outcomes of live birth rate.
Time frame: 36 months
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.
1 secondary outcome
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.
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Antonio Garcia Velasco, PhD principal investigator
IVIRMA MADRID
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reproductive Issues, run by IVI Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diana Alecsandru, PhD (+34 91 180 29 00, Diana.Alecsandru@ivirma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if certain combinations of maternal KIR and oocyte donor HLA-C genotypes results in improved outcomes of live birth rate. (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.