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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Endometritis
• Intervention / Treatment: Drug: Doxycycline combined with Medroxyprogesterone; Drug: Doxycycline combined with placebo

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fang Wang; Phone Number: 13919302888; Email: ery_fwang@lzu.edu.cn

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China, 730030
      • Recruiting
      • Lanzhou University Second Hospital
      • Contact: Fang Wang; Phone Number: 13919302888; Email: ery_fwang@lzu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: doxycycline combined with medroxyprogesterone acetate(MPA)	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
Active Comparator: doxycycline combined with placebo	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cure rate of chronic endometritis	At 8 weeks after completion of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From completion of treatment to the end of the follow-up period, with a minimum follow-up of 6 months.
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.	From completion of treatment to the end of follow-up, with a minimum follow-up of 6 months
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.	From completion of treatment to the end of follow-up, with a minimum follow-up of 6 months
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.	From completion of treatment to the end of follow-up, with a minimum follow-up of 6 months

Collaborators and Investigators

• Sponsor: Fang Wang
• Investigators: Principal Investigator: Fang Wang, Lanzhou University Second Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Polycyclic Compounds; Pregnanes; Steroids; Fused-Ring Compounds; Pregnenediones; Pregnenes; Hydroxyprogesterones; Progesterone; Medroxyprogesterone
• Other Study ID Numbers: 2023A-740

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No