Ignite Creation Date:
2024-05-06 @ 10:07 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03169621
Status:
TERMINATED
Last Update Posted:
2019-03-26
First Post:
2017-05-19
Brief Title:
Diagnosis of Chronic Endometritis in Endometrial Fluid Using Molecular Techniques to Improve the Outcomes of Assisted Reproductive Treatments
Sponsor:
Igenomix
Organization:
Igenomix
Study Overview
Official Title:
Diagnosis of Chronic Endometritis in Endometrial Fluid Using Molecular Techniques to Improve the Outcomes of Assisted Reproductive Treatments
Status:
TERMINATED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low patient enrolment during the recruiting period
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ChEndometritis
Brief Summary:
Chronic endometritis CE is a persistent inflammation of the endometrial lining caused by the infection of the uterine cavity mainly by bacterial pathogens It is known that CE can produce implantation failure recurrent abortion and preterm labor The study hypothesis is that patients who have repeated implantation failures RIF despite transferring good quality and normal embryos diagnosed by preimplantation Genetic Diagnosis PGD into a receptive endometrium diagnosed by Endometrial Receptivity Analysis ERA may present asymptomatic CE being the altered endometrium the main cause of these implantation failures
The current diagnosis of CE is the microbiological culture of endometrial biopsy samples Alternatively examination of the uterine cavity by hysteroscopy is effective at 934 However both methods have limitations such as the time needed to obtain the diagnosis the economic cost of the tests the possibility of detecting microorganisms in culture etc For these reasons the developing of a simple fast cheap and minimally invasive diagnostic tool for CE patients subjected to IVF treatments is expected It would be very useful in order to establish a specific treatment and improve pregnancy rates in infertile patients For this reason the bacterial DNA present in the endometrial fluid samples will be obtained and the identification of the causative pathogens of CE will be done by sequencing NGS andor quantitative PCR with specific oligonucleotides for the most common bacteria causing CE The validation of this new method will be performed by comparison with the microbiological diagnosis of those same patients
The current diagnosis of CE is the microbiological culture of endometrial biopsy samples Alternatively examination of the uterine cavity by hysteroscopy is effective at 934 However both methods have limitations such as the time needed to obtain the diagnosis the economic cost of the tests the possibility of detecting microorganisms in culture etc For these reasons the developing of a simple fast cheap and minimally invasive diagnostic tool for CE patients subjected to IVF treatments is expected It would be very useful in order to establish a specific treatment and improve pregnancy rates in infertile patients For this reason the bacterial DNA present in the endometrial fluid samples will be obtained and the identification of the causative pathogens of CE will be done by sequencing NGS andor quantitative PCR with specific oligonucleotides for the most common bacteria causing CE The validation of this new method will be performed by comparison with the microbiological diagnosis of those same patients
Detailed Description:
On day 5 of the Hormonal Replacement Therapy after 5 days of progesterone administration coinciding with the day of hysteroscopy indicated by the physician according to the routine clinical practice samples of endometrial fluid EF and endometrial biopsy EB of patients with RIF will be obtained These samples will be used for the diagnosis of CE by both classic and molecular methods Specifically EF sample will be analyzed by molecular techniques using Next Generation Sequencing NGS for the detection of infectious agents EB sample will be divided into three parts one of them will be used for molecular analysis as control of the bacterial content present in the EF another part will be subjected to microbiological analysis and the third part will be analyzed using histological techniques In this way comparisons will be made between the different diagnostic methods of CE in the two sample types EF and EB and the efficacy values of the new diagnostic test sensitivity specificity positive and negative predictive values and Receiving Operating Characteristic curves will be obtained using the microbiological diagnosis as a reference gold standard method
Patients with a negative outcome for CE approximately 40 will continue with the expected assisted reproduction treatment ART according to the clinics standard protocol and patients with a positive outcome for CE approx 60 will receive antibiotic treatment according to usual clinical practice time and type of antibiotic will be different according to the microbiological diagnosis Once this treatment is completed the improvement of these patients will be confirmed obtaining a second sample of EF and EB The Assisted Reproductive Treatment ART will be performed once the specialist considers it appropriated
Finally reproductive rates will be correlated with the diagnosis of CE Therefore an observational analytical study in which a comparison of the ART results before and after its diagnosis of CE will be carried out The reproductive impact of an altered endometrial microbiota will be assessed analyzing the implantation rates pregnancy and ongoing pregnancy
Patients with a negative outcome for CE approximately 40 will continue with the expected assisted reproduction treatment ART according to the clinics standard protocol and patients with a positive outcome for CE approx 60 will receive antibiotic treatment according to usual clinical practice time and type of antibiotic will be different according to the microbiological diagnosis Once this treatment is completed the improvement of these patients will be confirmed obtaining a second sample of EF and EB The Assisted Reproductive Treatment ART will be performed once the specialist considers it appropriated
Finally reproductive rates will be correlated with the diagnosis of CE Therefore an observational analytical study in which a comparison of the ART results before and after its diagnosis of CE will be carried out The reproductive impact of an altered endometrial microbiota will be assessed analyzing the implantation rates pregnancy and ongoing pregnancy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None