Intrauterine Antibiotic Infusion in Treating Chronic Endometritis and Restoring Reproductive Dynamics

NCT ID: NCT04447625

Last Updated: 2020-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2020-01-03

Brief Summary

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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).

Detailed Description

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Conditions

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Chronic Endometritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CE patients receiving OAA

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

Group Type ACTIVE_COMPARATOR

Oral antibiotic administration

Intervention Type DRUG

per os antibiotic administration as the standard line of strategy for treating CE of doxycycline at a dosage of 100mg twice a day for 14 days and metronidazole of 500mg twice a day for 14 days

CE patients receiving OAA and IAI

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

Group Type EXPERIMENTAL

Oral antibiotic administration

Intervention Type DRUG

per os antibiotic administration as the standard line of strategy for treating CE of doxycycline at a dosage of 100mg twice a day for 14 days and metronidazole of 500mg twice a day for 14 days

Intrauterine antibiotic infusion

Intervention Type DRUG

intrauterine infusion of 3ml of ciprofloxacin at a concentration of 200 mg/100 ml

Interventions

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Oral antibiotic administration

per os antibiotic administration as the standard line of strategy for treating CE of doxycycline at a dosage of 100mg twice a day for 14 days and metronidazole of 500mg twice a day for 14 days

Intervention Type DRUG

Intrauterine antibiotic infusion

intrauterine infusion of 3ml of ciprofloxacin at a concentration of 200 mg/100 ml

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Genesis Athens Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Human Reproduction LTD

Athens, Holargos, Greece

Site Status

Countries

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Greece

Other Identifiers

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1A

Identifier Type: -

Identifier Source: org_study_id

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