PREDICTIVE IMMUNOLOGICAL STUDY OF RECURRENT ABORTIONS AND IMPLANTATION FAILURE

NCT04052438 | Completed

• 1 other identifier: 1405-MAD-026-JG
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The involvement of the immune system in the process of implantation and its modulation as a therapeutic line in these alterations, failure of implantation and repetition abortion are controversial and make it necessary to conduct clinical studies properly led and with a study population chosen by strict criteria in order to better understand the involvement of the different innate and adaptive immune mechanisms in the field of reproductive medicine and especially in clinically expressed failures recurrent implantation failure and recurrent abortions.

Conditions

Maternal-Fetal KIR-HLA-C Compatibility

Outcome Measures

Primary Outcomes (1)

• Maternal genetic compatibility profile fetal KIR-HLA-C

  KIR AA, KIR AB, KIR BB

  2 years

Study Arms (2)

Patients with recurrent abortion.

More than three idiopathic involuntary miscarriages.

Diagnostic Test: HLA-C and KIR determination for patients, couples, oocyte or semen donors, abortive tissue and newborn.

Patients with implantation failure.

More than three IVF abortions with good quality embryos or more than two abortions in oocyte donation cycles.

Diagnostic Test: HLA-C and KIR determination for patients, couples, oocyte or semen donors, abortive tissue and newborn.

Interventions

HLA-C and KIR determination for patients, couples, oocyte or semen donors, abortive tissue and newborn. DIAGNOSTIC_TEST

Patients with implantation failure.; Patients with recurrent abortion.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women with a history of recurrent abortion or recurrent implantation failure
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with a history of recurrent abortion (more than 3 idiopathic involuntary abortions) or recurrent implantation failure (more than 3 failures of IVF cycles with good quality embryos or more 2 failures in cycles with donor eggs) that will undergo a cycle assisted reproduction

You may qualify if:

• Body mass index between 19 and 27 kg/m2
• Patients with 3 or more IVF failures following transfer of good quality embryos or with 2 or more failures following embryo transfer in egg donation cycles.
• At least one embryo transfer is required to have been made in a blastocyst state (embryo on day 5) and with the current partner/donor.
• Study of normal karitype..
• Normal thrombophilia study.
• Vaginal exudate (Chlamydia, ureaplasma) normal
• Normal immune study.
• Inclusión criteria in recurrent abortion:
• Body mass index between 19 and 27 kg/m2
• Patients with 3 or more recurrent abortions, natural gestations or after transfer of good quality embryos (own or ovodonation)
• Study of normal karitype.
• Normal thrombophilia study.
• Vaginal exudate (Chlamydia, ureaplasma) normal
• Normal immune study.

You may not qualify if:

• Pregnant or lactating women.
• They cannot offer cooperation.
• Patients with fibromes.
• Patients with PCOS.
• Patients with some genetic alteration (altered karitype, cystic fibrosis, multiple sclerosis, rheumatoid arthritis...)
• Patients chronic infectious disease.
• Patients in maintenance treatment with immunosuppressants.
• Patients who have received systemic corticosteroids in the last 4 weeks.
• Patients diagnosed with chronic lymphoproliferative disease.

Sponsors & Collaborators

• IVI Madrid: lead

Related Publications (4)

• Adams EJ, Parham P. Species-specific evolution of MHC class I genes in the higher primates. Immunol Rev. 2001 Oct;183:41-64. doi: 10.1034/j.1600-065x.2001.1830104.x.

  PMID: 11782246 RESULT

• Apps R, Murphy SP, Fernando R, Gardner L, Ahad T, Moffett A. Human leucocyte antigen (HLA) expression of primary trophoblast cells and placental cell lines, determined using single antigen beads to characterize allotype specificities of anti-HLA antibodies. Immunology. 2009 May;127(1):26-39. doi: 10.1111/j.1365-2567.2008.03019.x.

  PMID: 19368562 RESULT

• Arck PC, Hecher K. Fetomaternal immune cross-talk and its consequences for maternal and offspring's health. Nat Med. 2013 May;19(5):548-56. doi: 10.1038/nm.3160. Epub 2013 May 7.

  PMID: 23652115 RESULT

• Alecsandru D, Barrio A, Garrido N, Aparicio P, Pellicer A, Moffett A, Garcia-Velasco JA. Parental human leukocyte antigen-C allotypes are predictive of live birth rate and risk of poor placentation in assisted reproductive treatment. Fertil Steril. 2020 Oct;114(4):809-817. doi: 10.1016/j.fertnstert.2020.05.008. Epub 2020 Jul 31.

  PMID: 32741616 DERIVED

Study Officials

• Diana Alecsandru

  IVI Madrid

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 9, 2019
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share