Chronic Endometritis
Conditions
Brief summary
A Prospective Randomized Controlled Trial, the goal of this clinical trial is to evaluate the efficacy and safety of doxycycline alone versus doxycycline plus medroxyprogesterone acetate (MPA) in women with chronic endometritis (CE), and to assess subsequent reproductive outcomes. Participants will be randomly assigned to one of two groups and will receive the assigned treatment. Participants will be followed for reproductive outcomes, including pregnancy , ongoing pregnancy, spontaneous miscarriage, and live birth.
Interventions
DRUGDoxycycline combined with Medroxyprogesterone
doxycycline 200 mg/day (100 mg twice daily) combined with medroxyprogesterone acetate(MPA) 24 mg/day (8 mg three times daily) for 14 days
DRUGDoxycycline combined with placebo
doxycycline 200 mg/day (100 mg twice daily) with placebo 24 mg/day (8 mg three times daily) for 14 days
Sponsors
Fang Wang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* women aged 20-45 years; * plans to conceive within 12 months; * chronic endometritis(CE) confirmed by endometrial CD138 immunohistochemistry (IHC); * a diagnosis of recurrent reproductive failure(RRF); * willingness to undergo hysteroscopy and endometrial biopsy; * no contraindications to the study medications.
Exclusion criteria
* acute genital tract infection, gynecologic malignancy, endometrial hyperplasia, or uterine fibroids; * pregnancy or lactation; * contraindications to hysteroscopy or anesthesia; * use of antibiotics, glucocorticoids, estrogens, or progestins within 3 months before trial initiation; * allergy to doxycycline or medroxyprogesterone acetate(MPA); * abnormal semen parameters in the male partner.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure rate of chronic endometritis | At 8 weeks after completion of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pregnancy rate | From completion of treatment to the end of the follow-up period, with a minimum follow-up of 6 months. | Pregnancy was defined as a pregnancy confirmed after completion of treatment, including biochemical pregnancy. Only the first pregnancy after completion of treatment was included in the analysis. |
| Live birth rate | From completion of treatment to the end of follow-up, with a minimum follow-up of 6 months | Live birth was defined as delivery of a live infant at or beyond 24 weeks of gestation. Only the first pregnancy after completion of treatment was included in the analysis. |
| Rate of pregnancy loss | From completion of treatment to the end of follow-up, with a minimum follow-up of 6 months | Pregnancy loss was defined as spontaneous loss of a pregnancy before 24 weeks of gestation. Only the first pregnancy after completion of treatment was included in the analysis. |
| sustained pregnancy rate | From completion of treatment to the end of follow-up, with a minimum follow-up of 6 months | Sustained pregnancy was defined as a pregnancy lasting for at least 12 weeks of gestation. Only the first pregnancy after completion of treatment was included in the analysis. |
Countries
China
Contacts
CONTACTFang Wang
PRINCIPAL_INVESTIGATORFang Wang
Lanzhou University Second Hospital
Outcome results
None listed