Abortion, HabitualmicroRNA410NCT05658445
Potential Role of microRNA 410 and BIRC7 Pathways in Recurrent Spontaneous Miscarriage
An observational study of Abortion, Habitual, run by Assiut University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion, Habitual
- What is being tested?
- evacuation
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Jun 2025
- How long will I take part?
- 30 Months
- 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 20 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Female without cancer or chronic illness that exposed to 2 or 3 consecutive or discontinues abortion
Who may be able to join
None listed.
Who cannot join
- Female with one miscarriage
- Female with explained causes of miscarriage
- Female with cancer
- Female with chronic illness.
- Pregnant women above 30
Trial locations and contacts
1 site in 1 country.
About this study
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)
Read the detailed description
- 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
- Abortion, Habitual
- Being tested
- evacuation
- Keywords
- RSA
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evacuationOther
after complete evacuation of uterus follow abortion
| Study group | Role | What they receive |
|---|---|---|
| cases | Female with recurrent unexplained abortion Receives: Other: evacuation | |
| control | female with normal labour Receives: Other: evacuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define a novel hypothesis that may explain the aetiology of URSA
Measured: within 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start1 Jan 2023
- Primary completion1 Apr 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abortion, HabitualStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
- Target duration
- 30 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Gamal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658445
- Sponsor's protocol ID
- As
- Acronym
- microRNA410
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2022
- Last updated
- 31 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
G Farag N, O Mohamed A, Abdel-Aleem M, S El-Deeb T, A Elghazally S, G Elnaggar M, Al-Husseini A, A Gaber M. Potential Role of MicroRNA-410-5p and BIRC7 Gene Pathways in Recurrent Miscarriage in an Egyptian Population. Mol Biol Rep. 2026 Apr 17;53(1):630. doi: 10.1007/s11033-026-11712-2.
PubMed 41995997
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Role of microRNA 410 and BIRC7 Pathways in Recurrent Spontaneous Miscarriage
- ClinicalTrials.gov ID
- NCT05658445
- Acronym / sponsor ID
- microRNA410 / As
- Conditions
- Abortion, Habitual
- Keywords
- RSA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 20 Dec 2022 (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.
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
- 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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | Other: evacuationFemale with recurrent unexplained abortion |
| control | – | Other: evacuationfemale with normal labour |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female without cancer or chronic illness that exposed to 2 or 3 consecutive or discontinues abortion
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Female with one miscarriage
- Female with explained causes of miscarriage
- Female with cancer
- Female with chronic illness.
- Pregnant women above 30
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 |
|---|---|---|
| evacuationafter complete evacuation of uterus follow abortion | Other | cases, control |
Primary outcome
Define a novel hypothesis that may explain the aetiology of URSA
Time frame: within 3 years
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 31 Dec 2025.
- Derived from this study: PubMed 41995997G Farag N, O Mohamed A, Abdel-Aleem M, S El-Deeb T, A Elghazally S, G Elnaggar M, Al-Husseini A, A Gaber M. Potential Role of MicroRNA-410-5p and BIRC7 Gene Pathways in Recurrent Miscarriage in an Egyptian Population. Mol Biol Rep. 2026 Apr 17;53(1):630. doi: 10.1007/s11033-026-11712-2.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abortion, Habitual, run by Assiut University at 1 site in Egypt.
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 0 inclusion and 5 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 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
Define a novel hypothesis that may explain the aetiology of URSA (time frame: within 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05658445, which also lists 1 linked publication.
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 31 Dec 2025.