Doxycycline and Progestin Therapy for Chronic Endometritis(CE) in Patients With Recurrent Reproductive Failure(RRF)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Doxycycline combined with Medroxyprogesterone, Doxycycline combined with placebo.
- Who it may be relevant to
- Registry conditions: Chronic Endometritis. Basic parameters: 20 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Efficacy and Pregnancy Outcomes of Doxycycline Combined With Medroxyprogesterone Acetate Therapy for Chronic Endometritis(CE) in Patients With Recurrent Reproductive Failure(RRF): A Prospective Randomized Controlled Trial
Overview
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
- Drug Doxycycline 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 - Drug Doxycycline combined with placebo
doxycycline 200 mg/day (100 mg twice daily) with placebo 24 mg/day (8 mg three times daily) for 14 days
Primary outcome measures
- Cure rate of chronic endometritis [Time frame: At 8 weeks after completion of treatment]
Secondary outcome measures (4)
- pregnancy rate [Time frame: From completion of treatment to the end of the follow-up period, with a minimum follow-up of 6 months.]
- Live birth rate [Time frame: From completion of treatment to the end of follow-up, with a minimum follow-up of 6 months]
- Rate of pregnancy loss [Time frame: From completion of treatment to the end of follow-up, with a minimum follow-up of 6 months]
- sustained pregnancy rate [Time frame: From completion of treatment to the end of follow-up, with a minimum follow-up of 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Lanzhou University Second Hospital — Lanzhou
Identifiers
NCT: NCT07488949 · 2023A-740