InfertilityNCT02718105
Maternal and Fetal Compatibility in Assisted Reproductive Technology (ART)-Oocyte Donor Influences Live Birth Rate
An observational study of Infertility, run by IVI Madrid at 1 site in Spain.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- KIR HLAC determinations
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2022to 1 Aug 2022
- 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
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients undergoing an assisted reproductive treatment
Who may be able to join
- BMI 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.
Who cannot join
- Pregnancy women.
- Psychiatric disorders.
- Uterus alterations.
- Polycystic ovary syndrome
- Genetic and autoimmune diseases.
- Infectious diseases.
- Corticoid and immunosuppressant treatments previous.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal Killer Cell Immunoglobulin-like Receptors (KIR) and Fetal (Human Leukocyte Antigen) HLA-C Compatibility in ART-oocyte Donor Influences Live Birth Rate a Prospective Controlled Cohort Study
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
- Conditions
- Infertility
- Being tested
- KIR HLAC determinations
- Keywords
- KIR HLA-C, ART
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIR HLAC determinationsGenetic
We will take blood samples for KIR HLA-C determinations.
| Study group | Role | What they receive |
|---|---|---|
| Receiver patients in donor oocyte -ART | Maternal and fetal compatibility KIR HLA-C determinations in ART -oocyte donor Receives: Genetic: KIR HLAC determinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study start1 Jan 2022
- Primary completion1 Apr 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan A Garcia-Velasco, IVI Madrid
- Investigators
- Juan Antonio Garcia Velasco, PhD, Principal investigator, IVI Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718105
- Sponsor's protocol ID
- 1512-MAD-067-JG
- Status last verified
- Aug 2022
- First submitted
- 11 Mar 2016
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Killer Cell Immunoglobulin-like Receptors (KIR) and Fetal (Human Leukocyte Antigen) HLA-C Compatibility in ART-oocyte Donor Influences Live Birth Rate a Prospective Controlled Cohort Study
- ClinicalTrials.gov ID
- NCT02718105
- Acronym / sponsor ID
- 1512-MAD-067-JG
- Conditions
- Infertility
- Keywords
- KIR HLA-C, ART
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 24 Mar 2016 (estimated)
- 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.
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?
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Receiver patients in donor oocyte -ART | – | Genetic: KIR HLAC determinationsMaternal and fetal compatibility KIR HLA-C determinations in ART -oocyte donor |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients undergoing an assisted reproductive treatment
Key inclusion criteria (4 listed)
- BMI 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.
Key exclusion criteria (7 listed)
- Pregnancy women.
- Psychiatric disorders.
- Uterus alterations.
- Polycystic ovary syndrome
- Genetic and autoimmune diseases.
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 |
|---|---|---|
| KIR HLAC determinationsWe will take blood samples for KIR HLA-C determinations. | Genetic | Receiver patients in donor oocyte -ART |
Primary outcome
Compatibility maternal fetal KIR HLA-C
Time frame: 2 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- 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
IVI 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 Infertility, 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 11 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compatibility maternal fetal KIR HLA-C (time frame: 2 years). 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 Aug 2022.