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NCT03169621: ChEndometritis
Diagnosis of Chronic Endometritis in Endometrial Fluid Using Molecular Techniques to Improve the Outcomes of Assisted Reproductive Treatments
trial testing Endometrial Biopsy and endometrial fluid collection in Chronic Endometritis in 5 participants. Terminated before completion.
26 June 2018
Quick facts
| Lead sponsor | Igenomix |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 5 |
| Start date | 27 April 2017 |
| Primary completion | 26 June 2018 |
| Estimated completion | 13 February 2019 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Endometrial Biopsy and endometrial fluid collection
Conditions studied
- Chronic Endometritis — all drugs for Chronic Endometritis →
Sponsor
Igenomix
Who can join
Adults 18 to 38, female only, with Chronic Endometritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 93.4%. 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) and/or 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03169621
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Related trials
Other recruiting trials for Chronic Endometritis
Currently open trials in the same condition.
- NCT07180563 — Randomized Controlled Trial of Berberine in Combination With Doxycycline in the Treatment of Chronic Endometritis · Phase 1, PHASE2 · recruiting
- NCT07488949 — Doxycycline and Progestin Therapy for Chronic Endometritis(CE) in Patients With Recurrent Reproductive Failure(RRF) · NA · recruiting
Other Igenomix trials
Trials by the same sponsor.
- NCT06780605 — Correlation of the Genetic Constitution of the Spent Blastocyst Media · completed
- NCT04000152 — RCT Study to Validate niPGT-A Clinical Benefit. · NA · terminated
- NCT04466644 — COVID-19: A Prevalence Study of Two ART Centres After the Pandemic Lockdown in the USA (COVID-19 Free Clinics) · completed
- NCT04389658 — Contagiousness and Immunogenicity Status of COVID-19 in Asymptomatic Population (COVID-19 CONDITION) · completed
- NCT03673592 — Clinical Value of Mosaicism Diagnosis on the Trophectoderm Biopsies · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03169621 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Igenomix
- Last refreshed: 26 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03169621.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing