NCT07488949

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
66mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Apr 2024Dec 2031

Study Start

First participant enrolled

April 9, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

6.7 years

First QC Date

March 12, 2026

Last Update Submit

March 18, 2026

Conditions

Chronic Endometritis

Outcome Measures

Primary Outcomes (1)

  • Cure rate of chronic endometritis

    At 8 weeks after completion of treatment

Secondary Outcomes (4)

  • pregnancy rate

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

  • Live birth rate

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

  • Rate of pregnancy loss

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

  • sustained pregnancy rate

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

Study Arms (2)

doxycycline combined with medroxyprogesterone acetate(MPA)

EXPERIMENTAL
Drug: Doxycycline combined with Medroxyprogesterone

doxycycline combined with placebo

ACTIVE COMPARATOR
Drug: Doxycycline combined with placebo

Interventions

Doxycycline combined with MedroxyprogesteroneDRUG

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 medroxyprogesterone acetate(MPA)
Doxycycline combined with placeboDRUG

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

doxycycline combined with placebo

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lanzhou University Second Hospital

Lanzhou, Gansu, 730030, China

RECRUITING

MeSH Terms

Interventions

Medroxyprogesterone

Intervention Hierarchy (Ancestors)

HydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Fang Wang

    Lanzhou University Second Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang Wang

CONTACT

13919302888ery_fwang@lzu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 23, 2026

Study Start

April 9, 2024

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2031

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations

CN(1)