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

NCT03877939 | Completed

• 1 other identifier: 1801-SEV-009-MF
• Study Type: observational
• Target: 433
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Ectopic pregnancy; non-viable pregnancy; miRNA; Kisspeptin; β-HCG; biomarkers

Outcome Measures

Primary Outcomes (2)

• Level of Kisspeptin 54

  Level in peripheral blood of Kisspeptin 54

  Mar 2019 - Oct 2021

• Level of miR-324-3p

  Level in peripheral blood of miR-324-3p

  Mar 2019 - Oct 2021

Secondary Outcomes (7)

• Level of progesterone

  Mar 2019 - Oct 2021

• Level of hormone β-hCG

  Mar 2019 - Oct 2021

• Level of miRNAs related with insulin resistance, miR-424-5p and miR-15b

  Mar 2019 - Oct 2021

• Level of miRNAs related with insulin resistance, miR-424-5p and miR-15b

  Mar 2019 - Oct 2021

• KIR typing

  Mar 2019 - Oct 2021

Study Arms (5)

Non-pregnant patients

Patients with β-hCG test \< 10 UI/L.

Diagnostic Test: Blood samples collection for analysis

Patients with viable pregnancy

Patients with β-hCG test \> 10 UI/L whose pregnancy is confirmed between gestational weeks 6 and 8.

Diagnostic Test: Blood samples collection for analysis

Patients with biochemical pregnancy

Patients with β-hCG test \> 10 UI/L and without sac observed.

Diagnostic Test: Blood samples collection for analysis

Patients with ectopic pregnancy

Patients with β-hCG test \> 10 UI/L whose sac is implantated outside the uterine cavity.

Diagnostic Test: Blood samples collection for analysis

Patients with clinical miscarriage

Patients with β-hCG test \> 10 UI/L whose sac is implanted inside the uterine cavity, but non-viable pregnancy is confirmed before gestational week 8.

Diagnostic Test: Blood samples collection for analysis

Interventions

Blood samples collection for analysis DIAGNOSTIC_TEST

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.

Also known as: Uterine biopsy sample collection (only in biochemical pregnancy patients)

Non-pregnant patients; Patients with biochemical pregnancy; Patients with clinical miscarriage; Patients with ectopic pregnancy; Patients with viable pregnancy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Those patient that have made a pre-embryonic transfer in the IVI RMA Seville, IVI RMA Madrid, IVI RMA Valencia, and IVI RMA Barcelona clinics will constitute patient population.

You may qualify if:

• Patients who will perform SET.
• Patients using own oocytes.

You may not qualify if:

• Complicated uterine cavity.

Sponsors & Collaborators

• Vida Recoletas Sevilla: lead
• IVI Madrid: collaborator
• Instituto Valenciano de Infertilidad, IVI VALENCIA: collaborator
• IVI Barcelona: collaborator

Study Sites (2)

IVI RMA Madrid

Madrid, Madrid, 28023, Spain

Location

IVI RMA Seville

Seville, Seville, 41011, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples will be collected to analyze: * Progesterone * miRNA-324-3p * Kisspeptin 54 * KIR * HLA-C * miR-424-5p and miR-15b * Oral glucose tolerance test (OGTT) Additionaly, in patients with biochemical pregnancy, uterine biopsy samples will be collected to analyze: \- miR-424-5p and miR-15b

MeSH Terms

Conditions

Pregnancy, Ectopic

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Manuel Fernández-Sánchez, PhD, MD

  IVI RMA Seville

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: September 15, 2019
• Primary Completion: December 30, 2024
• Study Completion: March 20, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

ES (2)