The effectiveness of intrauterine antibiotic infusion versus oral antibiotic therapy in the treatment of chronic endometritis in patients during IVF (in vitro fertilization) procedures
| ISRCTN | ISRCTN17542620 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17542620 |
- Submission date
- 08/09/2022
- Registration date
- 14/09/2022
- Last edited
- 19/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
This study aims to demonstrate the infectious nature of chronic endometritis (CE) and to find the best therapeutic option.
Who can participate?
Female patients, who will be treated for infertility at the CALLA Infertility Center Oradea, with an in vitro fertilization (IVF) procedure
What does the study involve?
This study involves, beside the IVF procedure, a hysteroscopy in order to visualise the uterine cavity and obtain a probe (biopsy) of the lining (mucosa) for the diagnosis of CE. If the result turns out positive, the patient can choose how the disease will be treated. After the treatment, another biopsy will be obtained to confirm the effects of the treatment.
What are the possible benefits and risks of participating?
The benefits of participation are the diagnosis of the disease and the treatment of it. The risks associated with participation include possible allergic reactions to the antibiotics.
Where is the study run from?
CALLA Infertility Center (Romania)
When is the study starting and how long is it expected to run for?
January 2020 to May 2022
Who is funding the study?
CALLA Infertility Center (Romania)
Who is the main contact?
Anca Huniadi, ancahuniadi@gmail.com
Contact information
Principal Investigator
CA Rostti, No 1
Oradea
410103
Romania
 ORCID ID |
0000-0002-5998-9488 |
|---|---|
| Phone | +40744586923 |
| ginecologie@calla.ro |
Principal Investigator
CA Rostti, No 1
Oradea
410103
Romania
| Phone | +40744586923 |
|---|---|
| ancahuniadi@gmail.com |
Study information
| Study design | Prospective case-control study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The effectiveness of intrauterine antibiotic infusion versus oral antibiotic therapy in the treatment of chronic endometritis in patients during IVF (in vitro fertilization) procedures |
| Study acronym | Endo_Treat_Trial |
| Study hypothesis | To demonstrate the predominant infectious nature of chronic endometritis (CE) and to find the best therapeutic option by comparing the results of oral antibiotic therapy versus intrauterine antibiotic infusion in patients with CE undergoing IVF procedures |
| Ethics approval(s) | Approved 05/02/2020, Research Ethics Committee of Calla Clinic (Centrul de diagnostic și tratament al infertilității Calla, Constantin A Rosetti, No 1, 410103, Oradea, Romania; +40740 083 964; mihai_drf@yahoo.com), ref: 463/05.02.2020 |
| Condition | Chronic endometritis |
| Intervention | Chronic endometritis was diagnosed through hysteroscopy and immunohistochemistry for CD 138. Patients in both groups were tested for CE twice to evaluate the cure rate after oral combination antibiotic therapy versus intrauterine infusion of antibiotics. Hysteroscopy was performed under intravenous general anesthesia, after the disinfection of the perineum. The uterine mucosa was visualized by crossing the cervical canal with a compact hysteroscope CAMPO TROPHYSCOPE® (Karl Storz SE & Co. KG, Germany). Entering the uterine cavity, we look for the two tubal ostia and a panoramic image of the uterus. With biopsy forceps, we draw a mucosal probe from the macroscopical modified region (polyposis endometrium, oedema or hyperemia of endometrial mucosa). If there are no visible endometrial alterations, we extract a biopsy with a catheter (Gynetics Medical Products Endometrial Curette) that is crossing under visual observation of the cervical canal without any contact with the vaginal wall. Each patient chose the treatment after a thorough individual presentation of the method of administration, duration of treatment and side effects. In oral antibiotic treatment, we use a combination of 3 antibiotics over a 14-day period: ciprofloxacin 500 mg 2 times a day, doxycycline 100 mg 2 times a day and metronidazole 500 mg de 2 times a day. Our protocol for intrauterine antibiotic infusions includes the administration of 3 ml ciprofloxacin 200 mg/100 ml concentration every 3 days with 10 infusions in total across a 30-day period for each patient. In the follicular phase of the menstrual cycle following antibiotic therapy, all women underwent a follow-up endometrial biopsy with CD 138 immunohistochemical examination. The purpose is to have a negative result for chronic endometritis in patients undergoing an IVF procedure. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ciprofloxacin, doxycycline, metronidazole |
| Primary outcome measure | 1. Prevalence of chronic endometritis (CE) in a population that undergoes an IVF procedure measured using immunohistochemistry staining for CD 138 positivity over 1 year 2. Rate of CE resolution in patients receiving oral versus an intrauterine infusion of antibiotics measured using immunohistochemistry staining for CD 138 negativity at the control biopsy over 1 year |
| Secondary outcome measures | Correlation of the hysteroscopic aspect with the positive CD 138 immunohistochemical staining measured by the number of pathological hysteroscopies that also have positive CD 138 staining over 1 year |
| Overall study start date | 05/01/2020 |
| Overall study end date | 01/05/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 200 |
| Total final enrolment | 232 |
| Participant inclusion criteria | 1. Undergoing an IVF procedure at the clinic following various IVF recommendations 2. Obtained at least two of day 5-6 blastocyst 3. Agreed to have hysteroscopic examination |
| Participant exclusion criteria | 1. Acute endometritis or other acute pelvic inflammatory disease 2. Placental remnants 3. Steroidal and antibiotic treatment within 3 months prior to diagnosis 4. Endometrial cancer or atypical hyperplasia 5. Refusal of procedure (hysteroscopy), or treatment for chronic endometritis |
| Recruitment start date | 01/01/2021 |
| Recruitment end date | 31/12/2021 |
Locations
Countries of recruitment
- Romania
Study participating centre
Oradea
410103
Romania
Sponsor information
Hospital/treatment centre
CA Rosetti Street, No 1
Oradea
410103
Romania
| Phone | +40359404404 |
|---|---|
| ginecologie@calla.ro | |
| Website | https://www.calla.ro |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 17/12/2022 | 19/12/2022 | Yes | No |
Editorial Notes
19/12/2022: Publication reference added.
06/12/2022: Internal review.
14/09/2022: Trial's existence confirmed by the Research Ethics Committee of Calla Clinic
