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NCT Number: NCT07488949

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

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.

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Key information

Conditions

Chronic Endometritis

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lanzhou University Second Hospital

Lanzhou, Gansu, 730030, China

Location status: Recruiting

Location contact

Fang Wang

CONTACT

[email protected]

13919302888

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Cure rate of chronic endometritis

    Time frame: At 8 weeks after completion of treatment

Secondary outcomes

  1. pregnancy rate

    Time frame: 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.

  2. Live birth rate

    Time frame: 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.

  3. Rate of pregnancy loss

    Time frame: 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.

  4. sustained pregnancy rate

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Wang

CONTACT

[email protected]

13919302888

Sponsors and collaborators

Lead sponsor

Fang Wang

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2030
Study completion
2031
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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