microRNA410: Potential Role of microRNA 410 and BIRC7 Pathways in Unexplained Recurrent Spontaneous Miscarriage

Sponsor
Nesma Gamal (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05658445
Collaborator
(none)
86
1.9

Study Details

Study Description

Brief 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 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)

Condition or Disease Intervention/Treatment Phase
  • Other: evacuation

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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
86 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Potential Role of microRNA 410 and BIRC7 Pathways in Unexplained Recurrent Spontaneous Miscarriage
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
cases

Female with recurrent unexplained abortion

Other: evacuation
after complete evacuation of uterus follow abortion

control

female with normal labour

Other: evacuation
after complete evacuation of uterus follow abortion

Outcome Measures

Primary Outcome Measures

  1. Define a novel hypothesis that may explain the aetiology of URSA [within 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 30 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes

Inclusion Criteria: maternal age is between 20 to 30 years and Gestational age before abortion less than 24 weeks.

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Nesma Gamal

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nesma Gamal, faculty of medicine Assuit university, Assiut University
ClinicalTrials.gov Identifier:
NCT05658445
Other Study ID Numbers:
  • As
First Posted:
Dec 20, 2022
Last Update Posted:
Dec 29, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nesma Gamal, faculty of medicine Assuit university, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 29, 2022