InfertilityNCT03105453
The Microbiome in Subfertility and Assisted Reproductive Technologies (ART)
An observational study of Infertility and Subfertility, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
To assess the impact of the female genital microbiome on ART outcome. 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
- Infertility, Subfertility
- What is being tested?
- 3 Sampling points
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2016to 2 Nov 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 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women undergoing in-vitro fertilization
Who may be able to join
- Caucasian women
- Women undergoing an in-vitro fertilization cycle (for the first or second time)
- Single embryo transfer
- Day 5 embryo transfer
- Gonadotropin-releasing hormone antagonist
- Anti-mullerian hormone > 0,69 and < 3,5 µg/L
- Body mass index ≤ 30 kg/m2
- Signed informed consent
Who cannot join
- Women suffering of chronic diseases which may impair pregnancy outcome (e.g. diabetes, chronic renal disease).
- Antibiotics within 3 weeks of sampling
- Surgical sperm retrieval
- In-vitro maturation
- Preimplantation genetic diagnosis
- Grade 3 or 4 endometriosis
- Patients unable to comprehend the investigational nature of the proposed study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Microbiome in Subfertility and Assisted Reproductive Technologies
To assess the impact of the female genital microbiome on ART outcome.
Read the detailed description
The main objective of this study is to learn more about which microbial spectra are negatively or positively impacting IVF pregnancy outcome. This information is needed before proceeding to the next step in which an adaptation of the microbiome can be attempted to improve IVF outcome. The study is expected to shed light over the possible influence of the microbiome on causes for subfertility, endometrial receptivity and obstetrical complications. A diagnostic link may be found with entities that are often unexplained today, e.g. (recurrent) miscarriage and repeated implantation failure.
- Conditions
- Infertility, Subfertility
- Being tested
- 3 Sampling points
- Keywords
- Assisted reproductive technologies, Microbiome
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 Sampling pointsOther
When entering the in-vitro fertilization/intracytoplasmatic sperm injection 4 samples will be harvested: a rectal swab, a cervical swab, a vaginal swab and an intra-uterine sample using an empty embryo catheter. After the ovarian stimulation treatment, the same patients will be sampled two more times: once at the moment of oocyte retrieval (rectal, cervical, vaginal and intra-uterine samples) and again just before the embryo transfer (at this stage, the embryo culture medium will be harvested, as well as an intra-uterine sample using the tip of an empty embryo inner catheter before the embryo transfer and a rectal sample)
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Women in the study arm will undergo microbiome samplings described in the interventions section (3 sampling points) Receives: Other: 3 Sampling points |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy
To determine if there Is there a association between the microbiome profile and pregnancy outcome after ART
Measured: 7 weeks
Secondary outcomes (4)
Baseline microbiome profile
Descriptive analysis of the microbiome present in women suffering of infertility
Measured: 1 week
Variation of microbiome profile during assisted reproductive technologies
Descriptive analysis of the microbiome present in women suffering of infertility according to the assisted reproductive technologies cycle stage
Measured: 5 weeks
Microbiome profile of the embryo culture
Descriptive analysis of the microbiome present in the embryo culture on the day of embryo transfer
Measured: 1 week
Live birth
To determine if there Is there a association between the microbiome profile and pregnancy outcome after assisted reproductive technologies
Measured: 43 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study startSep 2016
- Primary completion2 Nov 2020
- Study completion2 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blockeel Christophe, Universitair Ziekenhuis Brussel
- Investigators
- Christophe Blockeel, PhD, Study director, Clinical headJulie Bussche, Msc, Principal investigator, Research collaborator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105453
- Sponsor's protocol ID
- 2016/220
- Status last verified
- Nov 2020
- First submitted
- 13 Jan 2017
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Microbiome in Subfertility and Assisted Reproductive Technologies
- ClinicalTrials.gov ID
- NCT03105453
- Acronym / sponsor ID
- 2016/220
- Conditions
- Infertility, Subfertility
- Keywords
- Assisted reproductive technologies, Microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 10 Apr 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.
To assess the impact of the female genital microbiome on ART outcome.
Detailed description
The main objective of this study is to learn more about which microbial spectra are negatively or positively impacting IVF pregnancy outcome. This information is needed before proceeding to the next step in which an adaptation of the microbiome can be attempted to improve IVF outcome. The study is expected to shed light over the possible influence of the microbiome on causes for subfertility, endometrial receptivity and obstetrical complications. A diagnostic link may be found with entities that are often unexplained today, e.g. (recurrent) miscarriage and repeated implantation failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | – | Other: 3 Sampling pointsWomen in the study arm will undergo microbiome samplings described in the interventions section (3 sampling points) |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women undergoing in-vitro fertilization
Key inclusion criteria (8 listed)
- Caucasian women
- Women undergoing an in-vitro fertilization cycle (for the first or second time)
- Single embryo transfer
- Day 5 embryo transfer
- Gonadotropin-releasing hormone antagonist
Key exclusion criteria (7 listed)
- Women suffering of chronic diseases which may impair pregnancy outcome (e.g. diabetes, chronic renal disease).
- Antibiotics within 3 weeks of sampling
- Surgical sperm retrieval
- In-vitro maturation
- Preimplantation genetic diagnosis
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 |
|---|---|---|
| 3 Sampling pointsWhen entering the in-vitro fertilization/intracytoplasmatic sperm injection 4 samples will be harvested: a rectal swab, a cervical swab, a vaginal swab and an intra-uterine sample using an empty embryo catheter. After the ovarian stimulation treatment, the same patients will be sampled two more times: once at the moment of oocyte retrieval (rectal, cervical, vaginal and intra-uterine samples) and again just before the embryo transfer (at this stage, the embryo culture medium will be harvested, as well as an intra-uterine sample using the tip of an empty embryo inner catheter before the embryo transfer and a rectal sample) | Other | Study arm |
Primary outcome
Clinical pregnancy
Time frame: 7 weeks
To determine if there Is there a association between the microbiome profile and pregnancy outcome after ART
4 secondary outcomes
Baseline microbiome profile
Time frame: 1 week
Variation of microbiome profile during assisted reproductive technologies
Time frame: 5 weeks
Microbiome profile of the embryo culture
Time frame: 1 week
Live birth
Time frame: 43 weeks
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 3 Nov 2020.
- Principal research siteLink provided by the sponsor.
- 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.
Christophe Blockeel, PhD study director
Clinical head
Julie Bussche, Msc principal investigator
Research collaborator
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 Infertility and Subfertility, run by Universitair Ziekenhuis Brussel 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 8 inclusion and 7 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 3 Nov 2020. 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?
Clinical pregnancy (time frame: 7 weeks). 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 3 Nov 2020.