Endometrial Flora Characterization in Infertile WomenNCT03208595
Endometrial Flora in Women Undergoing IVF Treatments
An observational study of Endometrial Flora Characterization in Infertile Women, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Characterization of the female genital tract microbiome in women undergoing IVF treatment Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Endometrial Flora Characterization in Infertile Women
- What is being tested?
- Endometrial sampling of a Typical Embryo transfer catheter
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2017to 1 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Adult
Study population: patients undergoing transfer of a single euploid blastocyst .The specimen will be obtaine from the embryo transfer catheter.
Who may be able to join
- All undergoning IVF treatment
- Embryo transfer of one Blastocyst
Who cannot join
- More then one Embryo Transfer
- Recent antibacterial treatment
About this study
Official title: Endometrial Flora Sampling in Women Undergoing IVF/PGD Treatments
Characterization of the female genital tract microbiome in women undergoing IVF treatment
Read the detailed description
The primary goal With The purpose of our study is to examine the uterine microbiome by Next-generation sequencing of the bacteria specific regions .
Vaginal and uterine swabs will be taken in different women undergoing IVF /PGD. Novel bacteria and results of taxonomy assignments will be examine to find correlation of uterine flora with IVF and obstetrical outcomes.
The metagenomics approach will be used to seek previously unidentified bacterial species in the human upper genital tract.
- Being tested
- Endometrial sampling of a Typical Embryo transfer catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial sampling of a Typical Embryo transfer catheterDiagnostic test
Also called no intervention
no intervention no additional change from unit protocol
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess endometrial caracteristicas in fertile and infertile women using next generation sequencing of bacterial identification
Type of flora identified by next generation sequencing of bacterial identification
Measured: 2017-2020
To identify specific endometrial flora in association to faliure of IVF treatment
Type of flora identified by NGS
Measured: 2017-2020
to assess the feasibility of endometrial sampling in women undergoing embryo transfer by a standart transfer cateteher
Mode of endometrial sampling
Measured: 2017-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start1 Aug 2017 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial Flora Characterization in Infertile WomenStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208595
- Sponsor's protocol ID
- 0201-17
- Status last verified
- Jun 2017
- First submitted
- 26 Jun 2017
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Flora Sampling in Women Undergoing IVF/PGD Treatments
- ClinicalTrials.gov ID
- NCT03208595
- Acronym / sponsor ID
- 0201-17
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 5 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Characterization of the female genital tract microbiome in women undergoing IVF treatment
Detailed description
The primary goal With The purpose of our study is to examine the uterine microbiome by Next-generation sequencing of the bacteria specific regions .
Vaginal and uterine swabs will be taken in different women undergoing IVF /PGD. Novel bacteria and results of taxonomy assignments will be examine to find correlation of uterine flora with IVF and obstetrical outcomes.
The metagenomics approach will be used to seek previously unidentified bacterial species in the human upper genital tract.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- patients undergoing transfer of a single euploid blastocyst .The specimen will be obtaine from the embryo transfer catheter.
Key inclusion criteria (2 listed)
- All undergoning IVF treatment
- Embryo transfer of one Blastocyst
Key exclusion criteria (2 listed)
- More then one Embryo Transfer
- Recent antibacterial treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endometrial sampling of a Typical Embryo transfer catheterAlso: no interventionno intervention no additional change from unit protocol | Diagnostic test | – |
Primary outcome
To assess endometrial caracteristicas in fertile and infertile women using next generation sequencing of bacterial identification
Time frame: 2017-2020
Type of flora identified by next generation sequencing of bacterial identification
To identify specific endometrial flora in association to faliure of IVF treatment
Time frame: 2017-2020
Type of flora identified by NGS
to assess the feasibility of endometrial sampling in women undergoing embryo transfer by a standart transfer cateteher
Time frame: 2017-2020
Mode of endometrial sampling
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Flora Characterization in Infertile Women, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess endometrial caracteristicas in fertile and infertile women using next generation sequencing of bacterial identification (time frame: 2017-2020). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2017.