An observational study in Non-Viable Pregnancy, sponsored by Vida Recoletas Sevilla. Completed at 2 sites in Spain. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by Vida Recoletas Sevilla · Observational
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.
This is a pilot study in which we intend to determine the moment in which biomarkers begin to be detected in non-viable pregnancies, in order to subsequently be able to develop specific studies focused on that moment. The following visits will be required:
SCREENING VISIT: To be performed before β-hCG test. After recruitment and signing informed consent, patients will be assigned with a three-letter code identifying the clinic and three numbers indicating the order in which the patient is recruited by each clinic.
β-hCG VISIT: To be performed the day of the β-hCG test (week 4):
- Peripheral blood samples will be collected for Progesterone (P4), Kisspeptin 54 and miR-324-3p analysis.
In case of negative result, patient will be out of the study. In case of positive result, β-hCG test > 10 UI/L, patient will continue with the following visits.
SUBSEQUENT BLOOD EXTRACTION VISITS: To be performed on Mondays and Thursdays or Tuesdays and Fridays of each week from β-hCG test until non-viable pregnancy is confirmed or between weeks 6 and 8 when viable pregnancy is confirmed (a maximum of 10 blood sample extractions):
In case of pregnancy of unknown location (PUL), protocol will continue until VP or NVP is confirmed.
If NVP is confirmed before clinical pregnancy visit, patient will undergo an end of study visit.
CLINICAL PREGNANCY VISIT: To be performed between weeks 5+2 and 5+6, the same day that one of the subsequent blood extractions:
- A transvaginal ultrasound scan will be performed before the blood sample extraction.
In case of non-viable pregnancy, patient will perform the end of study visit. In case of clinical pregnancy, patient will continue with the following visits.
ONGOING PREGNANCY VISIT: To be performed between weeks 6 and 8, the same day that one of the subsequent blood extractions:
- A transvaginal ultrasound scan will be performed before the blood sample extraction. VP will be confirmed with this ultrasound scan.
In case of non-viable pregnancy, patient will undergo the end of study visit. In case of viable pregnancy, patient will undergo the end of study visit in week 10 of pregnancy.
END OF STUDY VISIT: To be performed after an ultrasound scan when NVP is confirmed or in week 10 of pregnancy. The following samples will be collected:
In case of ectopic pregnancy:
- Peripheral blood samples for Progesterone (P4), Kisspeptin 54 and miR-324-3p analysis.
In case of clinical miscarriage:
- Peripheral blood samples for Progesterone (P4), Kisspeptin 54 and miR-324-3p analysis.
In case of Biochemical pregnancy:
In case of viable pregnancy in week 10 of gestation:
83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.
This study's enrollment of 433 is above the median of 150 across 39 observational studies indexed under Pregnancy, Ectopic.
Browse Pregnancy, Ectopic studies →Vida Recoletas Sevilla is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with β-hCG test \< 10 UI/L.
Diagnostic Test: Blood samples collection for analysis
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 β-hCG test \> 10 UI/L and without sac observed.
Diagnostic Test: Blood samples collection for analysis
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 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
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)
Level of Kisspeptin 54
Level in peripheral blood of Kisspeptin 54
Time frame: Mar 2019 - Oct 2021
Level of miR-324-3p
Level in peripheral blood of miR-324-3p
Time frame: Mar 2019 - Oct 2021
Level of progesterone
Level in peripheral blood of progesterone
Time frame: Mar 2019 - Oct 2021
Level of hormone β-hCG
Level in peripheral blood of hormone β-hCG
Time frame: Mar 2019 - Oct 2021
Level of miRNAs related with insulin resistance, miR-424-5p and miR-15b
Level in peripheral blood of miR-424-5p and miR-15b in patients with viable and biochemical pregnancy
Time frame: Mar 2019 - Oct 2021
Level of miRNAs related with insulin resistance, miR-424-5p and miR-15b
Level in endometrial sample of miR-424-5p and miR-15b in patients with biochemical pregnancy
Time frame: Mar 2019 - Oct 2021
KIR typing
Killer-cell immunoglobulin-like receptors typing in patients with viable and biochemical pregnancy
Time frame: Mar 2019 - Oct 2021
HLA-C typing
HLA (human leucocyte antigens)-C typing in patients with viable and biochemical pregnancy and their partners
Time frame: Mar 2019 - Oct 2021
Oral glucose tolerance test (OGTT)
Including blood sample analysis before 75 g of glucose consumption and after 1h and 2 h.
Time frame: Mar 2019 - Oct 2021
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Sep 2019 to primary completion in Dec 2024, 63 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vida Recoletas Sevilla