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

Fang Wang1,000 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

1,000

Conditions

Chronic Endometritis

Interventions

Doxycycline combined with Medroxyprogesterone

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Cure rate of chronic endometritis

Time frame: At 8 weeks after completion of treatment

Secondary Outcomes

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.

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

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

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts