Infertility, FemaleNCT04168567
The Impact of Body Mass Index on the Endometrial Microbiome in IVF Treatments. Tampere Infertility Microbiome Project (TIMP).
An observational study of Infertility, Female, run by Tampere University Hospital at 1 site in Finland.
Trial summary
This study project is an observational trial involving 90 patients suffering from male type infertility. The patients are divided in two groups (45 patients per group) based on their body mass index (BMI). Read more about this study
- Who is it for?
- Ages 20 to 42 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Microbiome analysis
- How many people
- 91 participants
- Where
- 1 siteFinland
- Study dates
- 14 Aug 2020to 1 Sep 2023
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Study population: Obese and non-obese female with male-infertility
Who may be able to join
- Patients with male infertility scheduled for IVF treatment and fresh embryo transfer
- Primary or secondary male-type infertility
- BMI over 30 kg/m² or under 25 kg/m²
- Patient's willingness to participate
Who cannot join
- Patients with endometriosis or adenomyosis
- Use of antibiotics during IVF treatment or oocyte retrieval
- Technical diffuculties in embryo transfer or no embryos available for transfer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Protocol for a Prospective Study to Compare the Endometrial Microbiome in Patients With Body Mass Index Over 30 kg/m² Versus Under 25 kg/m².
This study project is an observational trial involving 90 patients suffering from male type infertility. The patients are divided in two groups (45 patients per group) based on their body mass index (BMI).
Read the detailed description
This study (Tampere Infertility Microbiome Project, TIMP) aims to clarify the differences in the microbiome variety between obese and normal-weight patients. The first group will consist of patients with the body mass index (BMI) over 30 kg/m², while the second group will include patients with a healthy weight BMI under 25. The samples will be collected at the time of embryo transfer and analyzed in a laboratory specialing in next-generation sequencing (NGS) techniques.
- Conditions
- Infertility, Female
- Being tested
- Microbiome analysis
- Keywords
- Microbiome, Microbiota, Obesity
- Medical subject headings
- Infertility, Female, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiome analysisDiagnostic test
Samples from TIMP microbiome project will be analyzed with NGS techniques.
| Study group | Role | What they receive |
|---|---|---|
| Obese patients | Patients with a BMI higher than 30kg/m² will be included in the first group. Receives: Diagnostic Test: Microbiome analysis | |
| Normal-weight patients | Patients with a BMI under 25 kg/m² will be included in the second group. Receives: Diagnostic Test: Microbiome analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome variety between groups
This study aims to investigate differences of endometrium microbiome and continuum of microbiota from anal to reproductive tract site between obese and normal-weight patients. Samples will be collected at the time of embryo transfer using embryo transfer catheter. The study will also examine pregnancy outcomes and microbiome differences in pregnant patients.
Measured: through study completion, 1-2 years from the starting date
Secondary outcomes (1)
Ongoing pregnancy rate
Ongoing pregnancy rate
Measured: up to 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start14 Aug 2020
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
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.
- More trials run by Tampere University HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katja Ahinko, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168567
- Sponsor's protocol ID
- R18068
- Status last verified
- Jun 2025
- First submitted
- 19 Sep 2019
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Protocol for a Prospective Study to Compare the Endometrial Microbiome in Patients With Body Mass Index Over 30 kg/m² Versus Under 25 kg/m².
- ClinicalTrials.gov ID
- NCT04168567
- Acronym / sponsor ID
- R18068
- Conditions
- Infertility, Female
- Keywords
- Microbiome, Microbiota, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 19 Nov 2019 (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.
This study project is an observational trial involving 90 patients suffering from male type infertility. The patients are divided in two groups (45 patients per group) based on their body mass index (BMI).
Detailed description
This study (Tampere Infertility Microbiome Project, TIMP) aims to clarify the differences in the microbiome variety between obese and normal-weight patients. The first group will consist of patients with the body mass index (BMI) over 30 kg/m², while the second group will include patients with a healthy weight BMI under 25. The samples will be collected at the time of embryo transfer and analyzed in a laboratory specialing in next-generation sequencing (NGS) techniques.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese patients | – | Diagnostic Test: Microbiome analysisPatients with a BMI higher than 30kg/m² will be included in the first group. |
| Normal-weight patients | – | Diagnostic Test: Microbiome analysisPatients with a BMI under 25 kg/m² will be included in the second group. |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Obese and non-obese female with male-infertility
Key inclusion criteria (4 listed)
- Patients with male infertility scheduled for IVF treatment and fresh embryo transfer
- Primary or secondary male-type infertility
- BMI over 30 kg/m² or under 25 kg/m²
- Patient's willingness to participate
Key exclusion criteria (3 listed)
- Patients with endometriosis or adenomyosis
- Use of antibiotics during IVF treatment or oocyte retrieval
- Technical diffuculties in embryo transfer or no embryos available for transfer
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 |
|---|---|---|
| Microbiome analysisSamples from TIMP microbiome project will be analyzed with NGS techniques. | Diagnostic test | Normal-weight patients, Obese patients |
Primary outcome
Microbiome variety between groups
Time frame: through study completion, 1-2 years from the starting date
This study aims to investigate differences of endometrium microbiome and continuum of microbiota from anal to reproductive tract site between obese and normal-weight patients. Samples will be collected at the time of embryo transfer using embryo transfer catheter. The study will also examine pregnancy outcomes and microbiome differences in pregnant patients.
1 secondary outcome
Ongoing pregnancy rate
Time frame: up to 2-3 months
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 25 Jun 2025.
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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.
Katja Ahinko principal investigator
Tampere University Hospital
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, Female, run by Tampere University Hospital at 1 site in Finland.
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 4 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 25 Jun 2025. 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 Finland. 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?
Microbiome variety between groups (time frame: through study completion, 1-2 years from the starting date). 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 25 Jun 2025.