Status:
COMPLETED
Intrauterine Antibiotic Infusion in Treating Chronic Endometritis and Restoring Reproductive Dynamics
Lead Sponsor:
Genesis Athens Clinic
Conditions:
Chronic Endometritis
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
- 5\<BMI\<29.9
- 18\<Patients' age\<40
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04447625
Start Date
March 1 2017
End Date
January 3 2020
Last Update
June 25 2020
Active Locations (1)
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1
Human Reproduction LTD
Athens, Holargos, Greece, 15562