EUCTR2019-000585-38-GBActive, not recruitingPhase 1
Chronic Endometritis and Recurrent Miscarriage - The CERM trial - The CERM Trial
niversity Hospitals Coventry and Warwickshire NHS Trust0 sites3,062 target enrollmentStarted: October 8, 2020Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 3,062
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
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
- •Taking a medication that may interact with doxycycline
- •Myasthenia Gravis.
- •Systemic lupus erythematosus (SLE).
- •Immunodeficiency disorder.
- •Alcohol dependency*
- •Long-term antibiotic(s) use.
- •Menstrual cycle =21 - =42 days.
- •Unable to give informed consent.
- •Participation in another clinical trial of an investigational medicinal product (CTIMP) within the last 90 days.
- •Women who are breast feeding.
- •Exclusion criteria – RCT
- •A course of antibiotics between screening registration and randomisation to RCT**
- •A delay of longer than three months between biopsy result and randomisation to RCT**
- •Known serious liver disease*1
- •Taking a medication that may interact with doxycycline
- •Any co-morbid disease or condition that would make the patient unsuitable for the trial*1
- •*As judged by a medically qualified doctor assessing trial eligibility informed by referral letter from GP and hospital records
- •**If a woman has a course of antibiotics between screening registration and randomisation or was registered for screening over three months before randomisation to the RCT they will not be eligible for trial randomisation at the time. These women should be given the option to re-screen and have another biopsy to confirm eligibility for randomisation.
- •1If a clinician has doubts about a participants’ suitability for the trial because of a long-term medical condition they should undertake a Full Blood Count (FBC) and Liver function tests (LFTs); in order for a woman to be included in the trial the following should apply:
- •WBC >3x10^9/L,
- •Neutrophils >1.5x10^9/L,
- •Platelets >75x10^9/L, Hb>100g/L
- •Bilirubin <1.5XULN*
- •AST/ALT <3xULN*
- •Albumin >30g/dL).
- •* ULN = Upper Limit of Normal
- •All required additional checks must be documented in the patients’ medical notes
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