EUCTR2019-000585-38-GB
Active, not recruiting
Phase 1
Chronic Endometritis and Recurrent Miscarriage - The CERM trial - The CERM Trial
niversity Hospitals Coventry and Warwickshire NHS Trust0 sites3,062 target enrollmentOctober 8, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Hospitals Coventry and Warwickshire NHS Trust
- Enrollment
- 3062
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria \- screening
- •Age \=18 to \<42
- •Two or more consecutive first trimester intrauterine miscarriages (\=14 weeks gestation).
- •Women who agree to use barrier methods of contraception during the following cycles: biopsy preparation, screening\-biopsy, waiting for the results and during the intervention.
- •Inclusion criteria \- RCT
- •Women with \=5 CD138\+ cells/10mm2\.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 1500
Exclusion Criteria
- •Exclusion criteria – screening
- •Treatable cause(s) of RM for example:
- •oantiphospholipid antibody syndrome
- •othyroid disease
- •oparental karyotypical abnormalities.
- •Known sub\-septate uterus.
- •Poorly controlled diabetes (HbA1c \>48mmol/mol)
- •Allergy to doxycycline or its excipients.
- •Doxycycline contraindicated
- •Antibiotics in the current menstrual cycle
Outcomes
Primary Outcomes
Not specified
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