RecruitingNot ApplicableNCT07488949

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


Sponsor

Fang Wang

Enrollment

1,000 participants

Start Date

Apr 9, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 45 Years

Inclusion Criteria6

  • 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 Criteria6

  • 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.

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Interventions

DRUGDoxycycline 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

DRUGDoxycycline combined with placebo

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


Locations(1)

Lanzhou University Second Hospital

Lanzhou, Gansu, China

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NCT07488949


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