CompletedPhase 2

Intrauterine Antibiotic Infusion in Treating Chronic Endometritis and Restoring Reproductive Dynamics

Greece80 participantsStarted 2017-03-01

Plain-language summary

Chronic Endometritis (CE) is related to infertility and entails a challenging management. This study investigates the treatment of off-label intrauterine antibiotic infusion (IAI) combined with oral antibiotic administration (OAA), and it assesses respective performance against the gold standard treatment of OAA. Data sourced herein reports on treatment efficiency and fertility restoration for both patients aiming to conceive naturally or via In Vitro fertilization (IVF).

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Positive diagnosis of CE * Recurrent Pregnancy Loss (RPL) or Recurrent Implantation Failure (RIF) * No previous live birth * FSH and LH levels -evaluated on day 2 of the menstrual cycle- \<12 IU/ml * AMH levels \>1.1ng/ml * Progesterone levels -evaluated on day 21 of the menstrual cycle- \> 2 and \<25 ng/ml * 18.5\<BMI\<29.9 * 18\<Patients' age\<40 Exclusion Criteria: * Diagnosed endometriosis or other related Pelvic Inflammatory Disorder (PID) * Current or previous cancer diagnosis * Auto-immune, genetic or reproductive disorders * Reproductive history of pregnancy loss due to genetic abnormalities * Male factor infertility diagnosis

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Treatment efficiency rate

Timeframe: Treatment efficiency rate was assessed immediately after treatment completion

Side-effects rate

Timeframe: Side-effects were monitored from treatment initiation until completion of treatment. Treatment duration: 14 days for Arm 1 and 30 days for Arm 2

Trial details

NCT IDNCT04447625

SponsorGenesis Athens Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02-28

View on ClinicalTrials.gov More Chronic Endometritis trials