Non-Viable PregnancyTESTKMNCT03877939
Detection of Kisspeptins and miRNAs in Patients With Non-viable Pregnancy
An observational study of Non-Viable Pregnancy, run by Vida Recoletas Sevilla at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Non-Viable Pregnancy
- What is being tested?
- Blood samples collection for analysis
- Type of treatment
- Pill or oral medicine
- How many people
- 433 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Sep 2019to 20 Mar 2025
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Patients who will perform SET.
- Patients using own oocytes.
Who cannot join
- Complicated uterine cavity.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
IVI RMA Madrid
Madrid, Madrid, 28023
IVI RMA Seville
Seville, Seville, 41011
About this study
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.
Read the detailed description
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):
- Peripheral blood samples will be collected Progesterone (P4), Kisspeptin 54 and miR-324-3p will be analysed in these samples. Blood collection will be performed each day in a different arm, allowing a period between extractions in each arm of one week.
- In addition, an optional transvaginal ultrasound scan will be performed before each blood sample if patient wishes.
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:
- Peripheral blood samples for Progesterone (P4), Kisspeptin 54 and miR-324-3p analysis.
- Blood sample for KIR typing.
- Blood samples of patient and partner for HLA-C typing. If partner does not attend to this visit, his sample may be collected in the following 3 weeks.
- Blood samples for detection of miRNAs related with insulin resistance, miR-424-5p and miR-15b.
- Oral glucose tolerance test (OGTT), including blood sample analysis before 75 g of glucose consumption and after 1h and 2 h.
- Uterine biopsy in the month in which the biochemical pregnancy is confirmed or in the following month (in P + 5) for detection of miRNAs related with insulin resistance, miR-424-5p and miR-15b.
In case of viable pregnancy in week 10 of gestation:
- Peripheral blood samples for Progesterone (P4), Kisspeptin 54 and miR-324-3p analysis.
- Blood sample for KIR typing.
- Blood samples of patient and partner for HLA-C typing. If partner does not attend to this visit, his sample may be collected in the following 3 weeks.
- Blood samples for detection of miRNAs related with insulin resistance, miR-424-5p and miR-15b.
- Data of an oral glucose tolerance test (OGTT) that patients perform routinely in the first trimester of pregnancy will be required.
- Conditions
- Non-Viable Pregnancy
- Being tested
- Blood samples collection for analysis
- Keywords
- Ectopic pregnancy, non-viable pregnancy, miRNA, Kisspeptin, β-HCG, biomarkers
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples collection for analysisDiagnostic test
Also called Uterine biopsy sample collection (only in biochemical pregnancy patients)
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-pregnant patients | Patients with β-hCG test < 10 UI/L. Receives: 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. Receives: Diagnostic Test: Blood samples collection for analysis | |
| Patients with biochemical pregnancy | Patients with β-hCG test > 10 UI/L and without sac observed. Receives: 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. Receives: 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. Receives: Diagnostic Test: Blood samples collection for analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Kisspeptin 54
Level in peripheral blood of Kisspeptin 54
Measured: Mar 2019 - Oct 2021
Level of miR-324-3p
Level in peripheral blood of miR-324-3p
Measured: Mar 2019 - Oct 2021
Secondary outcomes (7)
Level of progesterone
Level in peripheral blood of progesterone
Measured: Mar 2019 - Oct 2021
Level of hormone β-hCG
Level in peripheral blood of hormone β-hCG
Measured: 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
Measured: 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
Measured: Mar 2019 - Oct 2021
KIR typing
Killer-cell immunoglobulin-like receptors typing in patients with viable and biochemical pregnancy
Measured: Mar 2019 - Oct 2021
HLA-C typing
HLA (human leucocyte antigens)-C typing in patients with viable and biochemical pregnancy and their partners
Measured: 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.
Measured: Mar 2019 - Oct 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start15 Sep 2019
- Primary completion30 Dec 2024
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Viable PregnancyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vida Recoletas Sevilla
- Sponsor type
- University, hospital or other
- Collaborators
- IVI Madrid, Instituto Valenciano de Infertilidad, IVI VALENCIA, IVI Barcelona
- Responsible party
- Sponsor
- Investigators
- Manuel Fernández-Sánchez, PhD, MD, Principal investigator, IVI RMA Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877939
- Sponsor's protocol ID
- 1801-SEV-009-MF
- Acronym
- TESTKM
- Status last verified
- Jan 2026
- First submitted
- 14 Mar 2019
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Kisspeptins and miRNAs in Patients With Non-viable Pregnancy
- ClinicalTrials.gov ID
- NCT03877939
- Acronym / sponsor ID
- TESTKM / 1801-SEV-009-MF
- Conditions
- Non-Viable Pregnancy
- Keywords
- Ectopic pregnancy, non-viable pregnancy, miRNA, Kisspeptin, β-HCG, biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 433 participants (actual)
- Lead sponsor
- Vida Recoletas SevillaUniversity, hospital or other
- Collaborators
- IVI Madrid, Instituto Valenciano de Infertilidad, IVI VALENCIA, IVI Barcelona
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 18 Mar 2019 (actual)
- 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.
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.
Detailed description
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):
- Peripheral blood samples will be collected Progesterone (P4), Kisspeptin 54 and miR-324-3p will be analysed in these samples. Blood collection will be performed each day in a different arm, allowing a period between extractions in each arm of one week.
- In addition, an optional transvaginal ultrasound scan will be performed before each blood sample if patient wishes.
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:
- Peripheral blood samples for Progesterone (P4), Kisspeptin 54 and miR-324-3p analysis.
- Blood sample for KIR typing.
- Blood samples of patient and partner for HLA-C typing. If partner does not attend to this visit, his sample may be collected in the following 3 weeks.
- Blood samples for detection of miRNAs related with insulin resistance, miR-424-5p and miR-15b.
- Oral glucose tolerance test (OGTT), including blood sample analysis before 75 g of glucose consumption and after 1h and 2 h.
- Uterine biopsy in the month in which the biochemical pregnancy is confirmed or in the following month (in P + 5) for detection of miRNAs related with insulin resistance, miR-424-5p and miR-15b.
In case of viable pregnancy in week 10 of gestation:
- Peripheral blood samples for Progesterone (P4), Kisspeptin 54 and miR-324-3p analysis.
- Blood sample for KIR typing.
- Blood samples of patient and partner for HLA-C typing. If partner does not attend to this visit, his sample may be collected in the following 3 weeks.
- Blood samples for detection of miRNAs related with insulin resistance, miR-424-5p and miR-15b.
- Data of an oral glucose tolerance test (OGTT) that patients perform routinely in the first trimester of pregnancy will be required.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Non-pregnant patients | – | Diagnostic Test: Blood samples collection for analysisPatients with β-hCG test < 10 UI/L. |
| Patients with viable pregnancy | – | Diagnostic Test: Blood samples collection for analysisPatients with β-hCG test > 10 UI/L whose pregnancy is confirmed between gestational weeks 6 and 8. |
| Patients with biochemical pregnancy | – | Diagnostic Test: Blood samples collection for analysisPatients with β-hCG test > 10 UI/L and without sac observed. |
| Patients with ectopic pregnancy | – | Diagnostic Test: Blood samples collection for analysisPatients with β-hCG test > 10 UI/L whose sac is implantated outside the uterine cavity. |
| Patients with clinical miscarriage | – | Diagnostic Test: Blood samples collection for analysisPatients 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Patients who will perform SET.
- Patients using own oocytes.
Key exclusion criteria (1 listed)
- Complicated uterine cavity.
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 |
|---|---|---|
| Blood samples collection for analysisAlso: Uterine biopsy sample collection (only in biochemical pregnancy patients)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. | Diagnostic test | Non-pregnant patients, Patients with biochemical pregnancy, Patients with clinical miscarriage, Patients with ectopic pregnancy, Patients with viable pregnancy |
Primary outcome
Level of Kisspeptin 54
Time frame: Mar 2019 - Oct 2021
Level in peripheral blood of Kisspeptin 54
Level of miR-324-3p
Time frame: Mar 2019 - Oct 2021
Level in peripheral blood of miR-324-3p
7 secondary outcomes
Level of progesterone
Time frame: Mar 2019 - Oct 2021
Level of hormone β-hCG
Time frame: Mar 2019 - Oct 2021
Level of miRNAs related with insulin resistance, miR-424-5p and miR-15b
Time frame: Mar 2019 - Oct 2021
Level of miRNAs related with insulin resistance, miR-424-5p and miR-15b
Time frame: Mar 2019 - Oct 2021
KIR typing
Time frame: Mar 2019 - Oct 2021
HLA-C typing
Time frame: Mar 2019 - Oct 2021
Oral glucose tolerance test (OGTT)
Time frame: Mar 2019 - Oct 2021
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 13 Jan 2026.
- Individual participant dataSharing planned: Undecided
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.
Manuel Fernández-Sánchez, PhD, MD principal investigator
IVI RMA Seville
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Viable Pregnancy, run by Vida Recoletas Sevilla at 2 sites 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 2 inclusion and 1 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 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Level of Kisspeptin 54 (time frame: Mar 2019 - Oct 2021). The study lists 2 primary outcomes in all. 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 13 Jan 2026.