Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650540
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Levofloxacin Plus Metronidazole Suppositories Versus Levofloxacin Co-administered with Metronidazole Tablets in Chronic Endometritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Levofloxacin Plus Metronidazole Suppositories Versus Levofloxacin Co-administered with Metronidazole Tablets for the Treatment of Chronic Endometritis a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single randomised controlled trial The investigators plan to randomise 800 participants to the levofloxacin plus metronidazole suppositories versus levofloxacin co-administered with metronidazole tablets for the treatment of chronic endometritis in a 11 rate Primary outcome will be the live birth rate after the embryo transfer
Detailed Description:
Chronic endometritis CE is a pathological condition characterized by inflammation and destruction of the endometrium In this disease state microorganisms coexist with the hosts immune system in a balanced manner However for the majority of patients with CE clinical symptoms are nonspecific and atypical rendering diagnosis based on clinical signs or blood tests unreliable Consequently invasive procedures such as histopathological examination of the endometrium or hysteroscopy are often necessary to establish a definitive diagnosis The infiltration of plasma cells in the endometrial stroma associated with CE together with increased production of immunoglobulins and pro-inflammatory cytokines can reduce endometrial receptivity This reduction in receptivity can lead to an increased risk of female infertility lower pregnancy rates and reduced live birth rates which are linked to unexplained infertility repeated failure of embryo implantation and recurrent miscarriages While the etiology of CE remains elusive it is widely believed to be related to infection by pathogenic microorganisms such as Streptococcus Enterococcus faecalis Escherichia coli Staphylococcus Klebsiella pneumoniae Ureaplasma and Mycoplasma which can ascend from the vagina into the uterine cavity Preliminary basic research by investigators also supports the notion that bacterial infections are a leading cause of endometritis The mainstay of CE treatment currently involves oral antibiotics with a common regimen being colabitux 500 mg once daily for 14 days in combination with metronidazole 400 mg twice daily for 14 days However oral antibiotics can face issues such as drug resistance suboptimal local concentrations of the drug and a propensity to cause gastrointestinal side effects like nausea vomiting diarrhea abdominal distension and dermatological reactions like skin rashes and leukopenia which can lead to treatment interruptions and reduced efficacy in managing chronic endometritis Therefore there is a need to explore methods to enhance the treatment success rate of CE Metronidazole suppositories composed primarily of metronidazole are used vaginally to treat bacterial infections and other types of bacterial-induced vaginitis Acting directly on the local area these suppositories typically exhibit faster and more pronounced therapeutic effects without adversely affecting other tissues and organs Given that the vagina is connected to the uterine cavity via the cervix investigators hypothesized that local vaginal administration of the medication might be more effective This approach not only achieves higher local concentrations of the drug in the uterine cavity but also prevents ascending infection of vaginal bacteria
In the prospective randomized study conducted by investigators the efficacy of levofloxacin plus metronidazole suppository versus levofloxacin co-administered with metronidazole tablets was compared in patients with chronic endometritis By comparing the pregnancy outcomes of the two groups the aim was to identify a superior treatment strategy enhance treatment efficacy and improve clinical outcomes
Purpose The objective of this study is to investigate the efficacy of metronidazole therapy in enhancing treatment outcomes for chronic endometritis with the aim of increasing clinical pregnancy and live birth rates in IVF procedures reducing miscarriage rates and thereby offering a safer and more effective treatment option for participants with chronic endometritis who are considering pregnancy
Design This study is designed as a randomized controlled trial Study Population
Inclusion Criteria
1 Infertile participants between the ages of 20 and 42
2 Participants who have undergone hysteroscopy and endometrial biopsy resulting in a pathological diagnosis of chronic endometritis
3 Participants with a blood FSH level of 12 UL on the second day of their menstrual cycle
4 Participants who have provided informed consent and signed the consent form
Exclusion Criteria
1 Participants diagnosed with uterine submucosal fibroids a history of uterine malformations or previous corrective surgeries for such deformities uterine intrauterine adhesions or a history of pelvic tuberculosis or endometrial tuberculosis including cases with pathology suggesting endometrial tuberculosis
2 Participants or their partners with a history of fetal or child chromosomal abnormalities and those planning a pre-implantation genetic screening
3 Participants with a well-documented clear history of allergy to the study medication
In the prospective randomized study conducted by investigators the efficacy of levofloxacin plus metronidazole suppository versus levofloxacin co-administered with metronidazole tablets was compared in patients with chronic endometritis By comparing the pregnancy outcomes of the two groups the aim was to identify a superior treatment strategy enhance treatment efficacy and improve clinical outcomes
Purpose The objective of this study is to investigate the efficacy of metronidazole therapy in enhancing treatment outcomes for chronic endometritis with the aim of increasing clinical pregnancy and live birth rates in IVF procedures reducing miscarriage rates and thereby offering a safer and more effective treatment option for participants with chronic endometritis who are considering pregnancy
Design This study is designed as a randomized controlled trial Study Population
Inclusion Criteria
1 Infertile participants between the ages of 20 and 42
2 Participants who have undergone hysteroscopy and endometrial biopsy resulting in a pathological diagnosis of chronic endometritis
3 Participants with a blood FSH level of 12 UL on the second day of their menstrual cycle
4 Participants who have provided informed consent and signed the consent form
Exclusion Criteria
1 Participants diagnosed with uterine submucosal fibroids a history of uterine malformations or previous corrective surgeries for such deformities uterine intrauterine adhesions or a history of pelvic tuberculosis or endometrial tuberculosis including cases with pathology suggesting endometrial tuberculosis
2 Participants or their partners with a history of fetal or child chromosomal abnormalities and those planning a pre-implantation genetic screening
3 Participants with a well-documented clear history of allergy to the study medication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None