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The CERM trial

The CERM trial is investigating whether treatment with the antibiotic doxycycline before conception improves pregnancy outcomes for women with recurrent miscarriage* and chronic endometritis (inflammation of the womb lining)

* In this research trial, ‘recurrent miscarriage’ means two or more early miscarriages in a row.

If you might be interested in taking part in the CERM trial, here’s what you need to know:

CERM is a randomised, double-blind, placebo-controlled trial:

Randomised: The women who take part are given either the treatment drug (doxycycline) or a placebo – a dummy drug that has no active ingredients. A computer makes the selection so it is completely random.

Double-blind: The women in the study aren’t told whether they are taking the active medicine or the placebo – and neither are their doctors. So both are blinded to this information.

Placebo-controlled: Half the women in the study have the active medicine and half (the controls) have the placebo. The medicine that they receive looks exactly the same to them and their doctors, but a completely separate group keeps a record of which women have the doxycycline and which have the placebo.

Who can take part in the CERM trial?

You may be able to take part in the trial if you have had two or more early miscarriages in a row, OR if you have had two early miscarriages separated by a late miscarriage, an ectopic pregnancy or a molar pregnancy

AND

What would I need to do?

Not everyone who has recurrent miscarriage has endometritis, so before you can take part in the randomised controlled trial, the hospital trial team will need to take an endometrial biopsy (a small sample of tissue from your endometrium) and examine it under a microscope to find out if you do.

We (the university research team) estimate that half the women tested will have endometritis and so be able to take part in the randomised controlled trial.

If your results show that you do not have endometritis:
You will continue with your usual care. The hospital trial team will keep in touch and phone you every three months for 12 months to see if you have become pregnant. If you do get pregnant during the 12 months, the hospital trial team will keep in touch and record the outcome of your pregnancy.

If your results show that you have endometritis:
You may be eligible to take part in the randomised controlled trial. Whether you will receive doxycycline or the placebo (a dummy drug with no active ingredients) is decided by chance. You and the trial researchers will not know who is taking the doxycycline and who is taking the placebo, but they will be able to find this out if it becomes necessary for your clinical care.

You should start taking the capsules on the first day of your next menstrual cycle. The dose is one capsule twice a day, 12 hours apart, for 14 days.

The hospital trial team will keep in touch and phone you every three months to see if you have become pregnant. If you do get pregnant, the hospital trial team will keep in touch and record the outcome of your pregnancy.

Where is it taking place?

The following hospitals are currently recruiting patients:

New centres are opening regularly.

If you are interested in taking part, please visit https://warwick.ac.uk/cerm/informationforpatients/ to find local contact details.