NCT05658445

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 20, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2023

Enrollment Period

2.2 years

First QC Date

December 12, 2022

Last Update Submit

December 24, 2025

Conditions

Keywords

RSA

Outcome Measures

Primary Outcomes (1)

  • Define a novel hypothesis that may explain the aetiology of URSA

    within 3 years

Study Arms (2)

cases

Female with recurrent unexplained abortion

Other: evacuation

control

female with normal labour

Other: evacuation

Interventions

after complete evacuation of uterus follow abortion

casescontrol

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly females with URSA
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Female without cancer or chronic illness that exposed to 2 or 3 consecutive or discontinues abortion

You may qualify if:

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

You may not qualify if:

  • Female with one miscarriage
  • Female with explained causes of miscarriage
  • Female with cancer
  • Female with chronic illness.
  • Pregnant women above 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Bochemistry Department

Asyut, Assuit, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

placental samples (4×6 cm) will be collected from women with miscarriage. Placental tissue from healthy controls (females with normal or caesarean labour)will also be collected. Tissue samples will be removed from the central region of the placenta and processed within 30 min. All samples will be repeatedly rinsed with cold phosphate buffered saline (PBS), and maintained at -80 °C until genetic study of miR-410-5p expression, Integrin alpha-6gene expression and Baculoviral IAP Repeat Containing 7(BIRC7) expression by qRTPCR.

MeSH Terms

Conditions

Abortion, Habitual

Interventions

Emergency Shelter

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

DisastersEnvironmentEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
30 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
faculty of medicine Assuit university

Study Record Dates

First Submitted

December 12, 2022

First Posted

December 20, 2022

Study Start

January 1, 2023

Primary Completion

April 1, 2025

Study Completion

June 1, 2025

Last Updated

December 31, 2025

Record last verified: 2023-12

Locations