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 range18 Years – 40 Years

SexFEMALE

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

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