Potential Role of microRNA 410 and BIRC7 Pathways in Recurrent Spontaneous Miscarriage

NCT ID: NCT05658445

Last Updated: 2025-12-31

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

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-06-01

Brief Summary

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

The definition of recurrent spontaneous abortion (RSA) has changed over the years, and most societies now advocate defining RSA as two or three consecutive or discontinuous miscarriages with the same sexual partner before 24 weeks gestation

In recent years, the incidence of this disease has been on the rise, occurring in about 1%- 5% of pregnancy in women at childbearing age, and the success rate of second pregnancy in RSA females has been significantly reduced The etiology of RSA is extremely complex, including anatomical factors, genetic factors, endocrine factors, infectious and immune factors, and pre-thrombosis etiology.

However, the cause of the disease is unclear in half of patients and known as unexplained recurrent spontaneous abortion (URSA)

Detailed Description

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

* MicroRNA (miRNA) is a kind of non-coding single-stranded RNA molecule encoded by endogenous genes with a length of about 22 nucleotides . MiRNA negatively regulates gene expression mainly by binding to the 3 'untranslated region (3' UTR) of target mRNA to degrade the target mRNA or inhibit its translation . In recent years, there have been numerous reports about miRNA's involvement in the pathogenesis of RSA, and many of them have focused on how miRNA regulates trophoblast function.
* Additionally, microRNA (miR)-410-5p has been discovered to serve as oncogenes and tumor suppressors altering cell functions in numerous ways including proliferation, apoptosis, biochemistry metabolism, and inflammatory responses in different human malignancies, such as liver cancer, pancreatic cancer, colon cancer, and non-small cell lung cancer. Recent studies showed that miR-410-5p may be involved in the non-cancerous disorder processes such as RSA . Overexpression of miR-410-5p in trophoblast cells inhibited the polarization of M2 macrophages, while knockdown of miR-410-5p was beneficial to recruitment of trophoblast cell and promoted the polarization of M2 macrophages. Furthermore, MicroRNA (miR)-410-5p was discovered to bind with 3'-UTR of ITGA6 .
* The adhesion molecule integrin alpha-6 (ITGA6, CD49f), a member of the integrin family, is overexpressed in many cancers and enhances cell movement and signal output .
* Down-regulation of ITGA6 changed the biological function of trophoblast cells, inhibited cell proliferation, invasion and migration, and induced apoptosis. ITGA6 may affect the biological functions of trophoblast cells by regulating PI3K/AKT and MAPK signaling pathways. MAPK signaling promote apoptosis through inducing releasing of cytochrome c, which in turn induces further caspase activation (caspase-9 and the effector caspases-3, -6, and -7) .
* Baculoviral IAP Repeat Containing 7(BIRC7) encodes the protein Livin which is a member of the inhibitor of apoptosis protein (IAP) family. Livin consists of a single baculoviral IAP repeat domain (BIR) and a RING domian at the C-terminus. The protein inhibits apoptosis by inhibiting proteolytic activation of capsases.
* Currently, the interaction of BIRC7 and NK cells in endometrium/decidual remains unknown. BIRC7 in decidua cell may possess the ability to prevent NK cells from killing embryonic and extraembryonic cells, decreased level of BIRC7 and increased number of NK cells in the RM group attribute to the occurrence of miscarriage

Conditions

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

Abortion, Habitual

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

RSA

Study Design

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

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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

cases

Female with recurrent unexplained abortion

evacuation

Intervention Type OTHER

after complete evacuation of uterus follow abortion

control

female with normal labour

evacuation

Intervention Type OTHER

after complete evacuation of uterus follow abortion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

evacuation

after complete evacuation of uterus follow abortion

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Female with unexplained two or three consecutive or discontinuous miscarriages with the same sexual partner

Exclusion Criteria

1. Female with one miscarriage
2. Female with explained causes of miscarriage
3. Female with cancer
4. Female with chronic illness.
5. Pregnant women above 30
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nesma Gamal

faculty of medicine Assuit university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical Bochemistry Department

Asyut, Assuit, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

As

Identifier Type: -

Identifier Source: org_study_id