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Detection of Kisspeptins and miRNAs in Patients With Non-viable Pregnancy

NCT03877939 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 433

Last updated 2026-01-13

No results posted yet for this study

Summary

Ectopic pregnancy (EP) is a pathology that affects 3%-16% of pregnancies in humans, being the main cause of morbidity and maternal mortality in the first trimester of pregnancy worldwide. The relevance of this problem has led to a demand on the scientific community, to obtain specific and early biomarkers in the determination of EP. In this context, the investigator's group has previously confirmed that both kisspeptin 54 and miR-324-3p are specific, selective and precise biomarkers to identify those patients suffering an EP. However, the utility of a diagnostic test using both biomarkers and other related ones in a population with other types of non-viable pregnancies should still be analysed.

Conditions

  • Non-Viable Pregnancy

Interventions

DIAGNOSTIC_TEST

Blood samples collection for analysis

Blood samples: Blood samples will be collected for the determination of the levels of various biomarkers (Kisspeptins and miRNAs), which are molecules that regulate the expression of proteins and can serve as markers for predicting pregnancy viability. Additionally, after biochemical or week 10 of clinical pregnancy confirmation, blood samples will be collected for KIR and HLA-C typing, Oral glucose tolerance test (OGTT) and analysis of the levels of miRNAs related with insulin resistance, miR-424-5p and miR-15b. Uterine biopsy (only in patients with BP): Uterine biopsy samples will be collected also after biochemical pregnancy confirmation for the determination of the levels of miRNAs related with insulin resistance, miR-424-5p and miR-15b.

Sponsors & Collaborators

  • IVI Madrid

    collaborator OTHER

  • Instituto Valenciano de Infertilidad, IVI VALENCIA

    collaborator OTHER

  • IVI Barcelona

    collaborator OTHER

  • Vida Recoletas Sevilla

    lead OTHER

Principal Investigators

  • Manuel Fernández-Sánchez, PhD, MD · IVI RMA Seville

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-15
Primary Completion
2024-12-30
Completion
2025-03-20

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03877939 on ClinicalTrials.gov