Doxycycline with or without progestin for chronic endometritis in women with recurrent reproductive failure
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
This trial tests whether adding the progestin medroxyprogesterone acetate to doxycycline improves pregnancy outcomes for women with chronic endometritis and recurrent reproductive failure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Sponsor | Lanzhou University Second Hospital Academic / other |
| Locations | 1 site (Lanzhou, Gansu) |
| Trial ID | NCT07488949 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial assigns women aged 20–45 with CD138-confirmed chronic endometritis and recurrent reproductive failure to receive either doxycycline plus medroxyprogesterone acetate or doxycycline plus placebo. Participants must be planning to conceive within 12 months and will undergo hysteroscopy and endometrial biopsy at baseline. The study follows participants for reproductive outcomes including pregnancy, ongoing pregnancy, spontaneous miscarriage, and live birth. Safety and tolerability of the treatment regimens will also be monitored.
Who should consider this trial
Good fit: Women age 20–45 who have CD138-confirmed chronic endometritis, a diagnosis of recurrent reproductive failure, plan to conceive within 12 months, and have no contraindication to hysteroscopy or the study medications.
Not a fit: Women whose infertility is due to other causes such as uterine structural disease, active genital infection, male factor infertility, contraindications to the medications, pregnancy or lactation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding MPA to doxycycline could increase pregnancy and live birth rates for women with chronic endometritis and recurrent reproductive failure.
How similar studies have performed: Antibiotic treatment for chronic endometritis has shown some success in improving reproductive outcomes, but combining doxycycline with a progestin like MPA is relatively novel and not yet well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lanzhou, Gansu
- Lanzhou University Second Hospital — Lanzhou, Gansu, China (Recruiting)
Study contacts
- Principal investigator: Fang Wang — Lanzhou University Second Hospital
- Study coordinator: Fang Wang
- Email: ery_fwang@lzu.edu.cn
- Phone: 13919302888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.