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Doxycycline and Progestin Therapy for Chronic Endometritis(CE) in Patients With Recurrent Reproductive Failure(RRF)

ConditionChronic Endometritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-45
SponsorFang Wang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Doxycycline combined with Medroxyprogesterone

    Drug

    doxycycline 200 mg/day (100 mg twice daily) combined with medroxyprogesterone acetate(MPA) 24 mg/day (8 mg three times daily) for 14 days

  • Doxycycline combined with placebo

    Drug

    doxycycline 200 mg/day (100 mg twice daily) with placebo 24 mg/day (8 mg three times daily) for 14 days

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: doxycycline combined with medroxyprogesterone acetate(MPA)Experimental treatment 1 intervention
Group B: doxycycline combined with placeboActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cure rate of chronic endometritis

Time frame
At 8 weeks after completion of treatment

Secondary outcomes

1

pregnancy rate

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.

Time frame
From completion of treatment to the end of the follow-up period, with a minimum follow-up of 6 months.
2

Live birth rate

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.

Time frame
From completion of treatment to the end of follow-up, with a minimum follow-up of 6 months
3

Rate of pregnancy loss

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.

Time frame
From completion of treatment to the end of follow-up, with a minimum follow-up of 6 months
4

sustained pregnancy rate

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.

Time frame
From completion of treatment to the end of follow-up, with a minimum follow-up of 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fang Wang

Lead sponsor

Lanzhou University Second Hospital

Sponsor institution

Source ClinicalTrials.gov
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