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.
The CERM trial is not open to new participants and is completing final recruitment. We will share the results once they are published.
CERM is a randomised, double-blind, placebo-controlled trial (see ** at the bottom of this page.) Information on how the trial has been run is below.
Who is taking part in the CERM trial?
Those who are taking part have had two or more early miscarriages in a row, OR if they have had two early miscarriages separated by a late miscarriage, an ectopic pregnancy or a molar pregnancy
- They were between 18 and 41 years old
- They had no known treatable cause of miscarriage
- They were happy to use barrier contraception for 3 months
- They were not currently pregnant at the time they were recuited
What do participants need to do?
Not everyone who has recurrent miscarriage has endometritis, so before people could take part in the randomised controlled trial, the hospital trial team took an endometrial biopsy (a small sample of tissue from the endometrium) and examined it under a microscope to find out if they did have endometritis.
The university research team estimated that half the women tested would have endometritis and so be able to take part in the randomised controlled trial.
If the results showed that a participant did not have endometritis:
The participant continued with their usual care. The hospital trial team would keep in touch and phone the participant every three months for 12 months to see if they had become pregnant. If they did get pregnant during the 12 months, the hospital trial team would continue to keep in touch and record the outcome of that pregnancy.
If your results showed that a particpant had endometritis:
The participant might be eligible to take part in the randomised controlled trial. Whether they received doxycycline or the placebo (a dummy drug with no active ingredients) would be decided by chance. The participant and the trial researchers would not know who was taking the doxycycline and who was taking the placebo, but they would be able to find this out if it became necessary for clinical care.
The participant would start taking the capsules on the first day of their next menstrual cycle: one capsule twice a day, 12 hours apart, for 14 days.
The hospital trial team would keep in touch and phone the participant every three months to see if they had become pregnant. If they did get pregnant, the hospital trial team would keep in touch and record the outcome of that pregnancy.
If you are interested in finding out more, please visit https://warwick.ac.uk/cerm/informationfor patients/.
** A randomised, double-blind, placebo-controlled trial:
Randomised: The women who take part are given either the treatment drug 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 active medicine and which have the placebo.