Infertility, FemaleNCT03363828
The Temporo-spatial Dynamics of Genital Tract Microbiota
An observational study of Infertility, Female, run by Peter Humaidan at 2 sites in Denmark.
Trial summary
The investigators aim to examine the endometrium with state of the art sequencing techniques to investigate the endometrial microbiota. The endometrial microbiota has been perceived to be sterile, however, this seems incorrect from recent studies. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Estrofem
- How many people
- 27 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Oct 2017to 8 Jan 2021
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Infertile couples attending IVF treatment and referred to a segmentation protocol.
Who may be able to join
- Patients in IVF Freeze-all/segmentation treatment protocol.
- Written informed consent.
Who cannot join
- Uterine malformations
- HIV, Hepatitis B or C positivity. HPV CIN 2 or higher. Chlamydia trachomatis positivity.
- Any uncontrolled concomitant disease (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
The Fertility Clinic Skive
Skive, 7800
The Fertility Clinic, Regional Hospital of Skive
Skive, 7800
About this study
Official title: The Temporo-spatial Dynamics of Genital Tract Microbiota - an Observational Study in IVF-Freeze All Patients Treated With Estradiol
The investigators aim to examine the endometrium with state of the art sequencing techniques to investigate the endometrial microbiota. The endometrial microbiota has been perceived to be sterile, however, this seems incorrect from recent studies. Thus, the primary outcome is to compare the rate of ascending infection from the semen to the vagina to the endometrium and to investigate which bacteria are capable of inhabiting these environments. Furthermore, cervical mucus will be obtained in order to test for immunological, microbiological and mechanical properties that may be involved in ascending infection. Finally, the study aim to characterize the temporal changes in the vaginal microbiota during estrogenic treatment with Estrofem® or Vivelle Dot (R) for preparation of the endometrium prior to embryo transfer.
- Conditions
- Infertility, Female
- Being tested
- Estrofem
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstrofemDrug
Patients will be asked to obtain self-collected vaginal swabs from the mid-vagina from the beginning of their Estrofem® treatment
| Study group | Role | What they receive |
|---|---|---|
| Normal microbiota | Based on qPCR and Next gen sequencing | |
| Abnormal microbiota | Based on qPCR and Next gen sequencing Receives: Drug: Estrofem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of ascending infection/sharing of bacteria in the genital tract
Seminal, vaginal, cervical and endometrial samples will be compared at the time of oocyte retrieval.
Measured: This outcome data is measured at the day of oocyte retrieval.
Secondary outcomes (4)
Next generation sequencing techniques will be used to assess the vaginal microbiota.I.e. measure of relative abundances
Vaginal microbiota changes throughout the preparation of the endometrium for frozen embryo transfer.
Measured: Examined longitudinally throughout the segmentation cycle. The estimated time to event is 40 days from oocyte retrieval until frozen embryo transfer following a strict protocol.
qPCR to assess the vaginal microbiota. I.e. a quantitative measure Copies/mL.
Vaginal microbiota changes throughout the preparation of the endometrium for frozen embryo transfer.
Measured: Examined longitudinally throughout the segmentation cycle. The estimated time to event is 40 days from oocyte retrieval until frozen embryo transfer following a strict protocol.
Number of participants with a Clinical pregnancy
Tested by clinical pregnancy scan by ultrasound in week 7-9
Measured: 7-9 weeks after inclusion.
Number of participants with a Live birth
Tested by self-reported schemes
Measured: 36-42 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start1 Oct 2017
- Primary completion23 Sep 2019
- Study completion8 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Humaidan
- Sponsor type
- University, hospital or other
- Collaborators
- Statens Serum Institut
- Responsible party
- Sponsor-investigator, Peter Humaidan, Regionshospitalet Viborg, Skive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363828
- Sponsor's protocol ID
- 1-10-72-345-15
- Status last verified
- Feb 2021
- First submitted
- 29 Oct 2017
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Part of PhD project. Data will appear in the thesis and subsequent publications.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Temporo-spatial Dynamics of Genital Tract Microbiota - an Observational Study in IVF-Freeze All Patients Treated With Estradiol
- ClinicalTrials.gov ID
- NCT03363828
- Acronym / sponsor ID
- 1-10-72-345-15
- Conditions
- Infertility, Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Peter HumaidanUniversity, hospital or other
- Collaborators
- Statens Serum Institut
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 23 Sep 2019 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 6 Dec 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.
The investigators aim to examine the endometrium with state of the art sequencing techniques to investigate the endometrial microbiota. The endometrial microbiota has been perceived to be sterile, however, this seems incorrect from recent studies. Thus, the primary outcome is to compare the rate of ascending infection from the semen to the vagina to the endometrium and to investigate which bacteria are capable of inhabiting these environments. Furthermore, cervical mucus will be obtained in order to test for immunological, microbiological and mechanical properties that may be involved in ascending infection. Finally, the study aim to characterize the temporal changes in the vaginal microbiota during estrogenic treatment with Estrofem® or Vivelle Dot (R) for preparation of the endometrium prior to embryo transfer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal microbiota | – | –Based on qPCR and Next gen sequencing |
| Abnormal microbiota | – | Drug: EstrofemBased on qPCR and Next gen sequencing |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile couples attending IVF treatment and referred to a segmentation protocol.
Key inclusion criteria (2 listed)
- Patients in IVF Freeze-all/segmentation treatment protocol.
- Written informed consent.
Key exclusion criteria (3 listed)
- Uterine malformations
- HIV, Hepatitis B or C positivity. HPV CIN 2 or higher. Chlamydia trachomatis positivity.
- Any uncontrolled concomitant disease (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)
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 |
|---|---|---|
| EstrofemPatients will be asked to obtain self-collected vaginal swabs from the mid-vagina from the beginning of their Estrofem® treatment | Drug | Abnormal microbiota |
Primary outcome
Rate of ascending infection/sharing of bacteria in the genital tract
Time frame: This outcome data is measured at the day of oocyte retrieval.
Seminal, vaginal, cervical and endometrial samples will be compared at the time of oocyte retrieval.
4 secondary outcomes
Next generation sequencing techniques will be used to assess the vaginal microbiota.I.e. measure of relative abundances
Time frame: Examined longitudinally throughout the segmentation cycle. The estimated time to event is 40 days from oocyte retrieval until frozen embryo transfer following a strict protocol.
qPCR to assess the vaginal microbiota. I.e. a quantitative measure Copies/mL.
Time frame: Examined longitudinally throughout the segmentation cycle. The estimated time to event is 40 days from oocyte retrieval until frozen embryo transfer following a strict protocol.
Number of participants with a Clinical pregnancy
Time frame: 7-9 weeks after inclusion.
Number of participants with a Live birth
Time frame: 36-42 weeks after inclusion
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 9 Feb 2021.
- Individual participant dataSharing planned: Yes. Part of PhD project. Data will appear in the thesis and subsequent publications.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by Peter Humaidan at 2 sites in Denmark.
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 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 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Rate of ascending infection/sharing of bacteria in the genital tract (time frame: This outcome data is measured at the day of oocyte retrieval.). 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 9 Feb 2021.