Repeated Implantation FailureNCT03405883
Uterine Microbiome in Women with Repeated Implantation Failure and Normal Fertile Women
An observational study of Repeated Implantation Failure and Normal Fertile, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Characterization of the uterine microbiome in women with repeated implantation failure as well as in normal fertile women. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Repeated Implantation Failure, Normal Fertile
- What is being tested?
- Vaginal swab + endometrial biopsy
- How many people
- 13 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2018to 31 Dec 2018
- 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 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: * For RIF women: absence of pregnancy after transfer of in total 5 embryos of high quality embryos * For NF women: live birth after spontaneous conception or IUI (max 9x)
Who may be able to join
- Women between their 18th and 40th birthdays (max 39 years and 364 days at the day of signing the informed consent)
- Able to understand, read and speak Dutch and hence to provide written and oral informed consent
- Negative serological tests for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), Rapid plasma reagin (RPR) for syphilis
Who cannot join
- Hormonal contraception in current cycle
- Presence of intra-uterine device
- Antibiotic treatment in the current cycle
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Analysis of the Uterine Microbiome in Women with Repeated Implantation Failure and Normal Fertile Women
Characterization of the uterine microbiome in women with repeated implantation failure as well as in normal fertile women.
Read the detailed description
In the midluteal phase of the cycle, a vaginal swab and endometrial biopsy will be obtained.
- Conditions
- Repeated Implantation Failure, Normal Fertile
- Being tested
- Vaginal swab + endometrial biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal swab + endometrial biopsyOther
In the midluteal phase of the cycle, a vaginal swab (E swab) and endometrial biopsy (TAO brush) will be obtained.
| Study group | Role | What they receive |
|---|---|---|
| RIF (women with repeated implantation failure) | Transfer of at least 5 good quality embryos in IVF or ICSI cycles, without achieving pregnancy Receives: Other: Vaginal swab + endometrial biopsy | |
| NF (normal fertile women) | Spontaneous conception or conception after max 9 IUI cycles Receives: Other: Vaginal swab + endometrial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Midluteal uterine microbiome profile
Descriptive analysis of the uterine microbiome present
Measured: 1 week
Secondary outcomes (1)
Midluteal vaginal microbiome profile
Descriptive analysis of the vaginal microbiome present (quality control of endometrial sampling)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Repeated Implantation FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Hans Verstraelen, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405883
- Sponsor's protocol ID
- BE670201733152
- Status last verified
- Sep 2024
- First submitted
- 12 Jan 2018
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of the Uterine Microbiome in Women with Repeated Implantation Failure and Normal Fertile Women
- ClinicalTrials.gov ID
- NCT03405883
- Acronym / sponsor ID
- BE670201733152
- Conditions
- Repeated Implantation Failure, Normal Fertile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 23 Jan 2018 (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 uterine microbiome in women with repeated implantation failure as well as in normal fertile women.
Detailed description
In the midluteal phase of the cycle, a vaginal swab and endometrial biopsy will be obtained.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIF (women with repeated implantation failure) | – | Other: Vaginal swab + endometrial biopsyTransfer of at least 5 good quality embryos in IVF or ICSI cycles, without achieving pregnancy |
| NF (normal fertile women) | – | Other: Vaginal swab + endometrial biopsySpontaneous conception or conception after max 9 IUI cycles |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * For RIF women: absence of pregnancy after transfer of in total 5 embryos of high quality embryos * For NF women: live birth after spontaneous conception or IUI (max 9x)
Key inclusion criteria (3 listed)
- Women between their 18th and 40th birthdays (max 39 years and 364 days at the day of signing the informed consent)
- Able to understand, read and speak Dutch and hence to provide written and oral informed consent
- Negative serological tests for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), Rapid plasma reagin (RPR) for syphilis
Key exclusion criteria (3 listed)
- Hormonal contraception in current cycle
- Presence of intra-uterine device
- Antibiotic treatment in the current cycle
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 |
|---|---|---|
| Vaginal swab + endometrial biopsyIn the midluteal phase of the cycle, a vaginal swab (E swab) and endometrial biopsy (TAO brush) will be obtained. | Other | NF (normal fertile women), RIF (women with repeated implantation failure) |
Primary outcome
Midluteal uterine microbiome profile
Time frame: 1 week
Descriptive analysis of the uterine microbiome present
1 secondary outcome
Midluteal vaginal microbiome profile
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
Hans Verstraelen, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Repeated Implantation Failure and Normal Fertile, run by University Hospital, Ghent at 1 site in Belgium.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Midluteal uterine microbiome profile (time frame: 1 week). 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 19 Sep 2024.