Intrauterine Antibiotic Infusion in Treating Chronic Endometritis and Restoring Reproductive Dynamics

Genesis Athens Clinic

Status and phase: Completed; Phase 2

Conditions: Chronic Endometritis

Treatments: Drug: Oral antibiotic administration; Drug: Intrauterine antibiotic infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04447625

1A

Details and patient eligibility

About

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).

Enrollment: 80 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

CE patients receiving OAA

Active Comparator group

Description:

Patients diagnosed with CE receiving the gold standard treatment of oral antibiotic administration (OAA)

Treatment:

Drug: Oral antibiotic administration

CE patients receiving OAA and IAI

Experimental group

Description:

Patients diagnosed with CE receiving a combination of the gold standard treatment of oral antibiotic administration (OAA) and intrauterine antibiotic infusion (IAI)

Treatment:

Drug: Intrauterine antibiotic infusion

Drug: Oral antibiotic administration