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Completed

NCT Number: NCT04447625

Intrauterine Antibiotic Infusion in Treating Chronic Endometritis and Restoring Reproductive Dynamics

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).

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Key information

Conditions

Chronic Endometritis Genital Diseases Infertility Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Human Reproduction LTD

Athens, Holargos, 15562, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral antibiotic administration

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

Drug

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

Primary outcomes

  1. Treatment efficiency rate

    Time frame: Treatment efficiency rate was assessed immediately after treatment completion

    Negative results in all three diagnostic evaluations of CE namely hysteroscopic investigation, endometrial biopsy, along with histological analysis and microbiological culture indicating successful treatment of CE

  2. Side-effects rate

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

    Number of reports of minimal, mild, and moderate side-effects per treated patients

Secondary outcomes

  1. Clinical pregnancy rate

    Time frame: Clinical pregnancy rate was assessed 6-7 weeks following last menstrual period for patients that achieved a pregnancy. A time frame of 6 months was allowed for patients to achieve a pregnancy post treatment.

    Clinical pregnancy rate was defined by the presence of a fetal heartbeat at 6-7 weeks following last menstrual period (LMP)

  2. Live birth rate

    Time frame: A time frame of 40-41 weeks was allowed to assess live birth rate following patients' last menstrual period.

    Number of live births per clinical pregnancy

Sponsors and collaborators

Lead sponsor

Genesis Athens Clinic

Other

Registry information

Official study title

Introducing Intrauterine Antibiotic Infusion as a Novel Approach in Effectively Treating Chronic Endometritis and Restoring Reproductive Dynamics: A Pilot Study

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jun 25, 2020
Registry last updated
Jun 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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