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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

433 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-15

Study Completion Date

2025-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Determination of Circulating Placental Biomarkers Levels to Predict the Pregnancy Outcome of First Trimester After IVF.

NCT04387994

Infertility, Female First Trimester Spontaneous Abortion

COMPLETED

Efficiency of Comprehensive Chromosomal Testing of Trophectoderm Biopsies of Blastocysts in In Vitro Fertilization

NCT04758819

Infertility

RECRUITING NA

Activin A and Inhibin A in Predicting Outcome of Pregnancies of Unknown Location After Assisted Reproductive Technology

NCT01589016

Ectopic Pregnancies

COMPLETED

Study of Abnormally Fertilized Embryos

NCT06940973

Infertility (IVF Patients)

NOT_YET_RECRUITING

Risk of Ectopic Pregnancy and Variation of Luteal Estradiol and Progesterone Levels in IVF

NCT02793089

Ectopic Pregnancy

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Viable Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.