The Impact of Body Mass Index on the Endometrial Microbiome in IVF Treatments. Tampere Infertility Microbiome Project (TIMP).

June 19, 2025 updated by: Tampere University Hospital

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Obese and non-obese female with male-infertility

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obese patients
Patients with a BMI higher than 30kg/m² will be included in the first group.
Diagnostic test: Microbiome analysis
Samples from TIMP microbiome project will be analyzed with NGS techniques.
Normal-weight patients
Patients with a BMI under 25 kg/m² will be included in the second group.
Diagnostic test: Microbiome analysis
Samples from TIMP microbiome project will be analyzed with NGS techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, 1-2 years from the starting date

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy rate
Time Frame: up to 2-3 months
Ongoing pregnancy rate
up to 2-3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Investigators

  • Principal Investigator: Katja Ahinko, Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2020

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

September 19, 2019

First Submitted That Met QC Criteria

November 18, 2019

First Posted (Actual)

November 19, 2019

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 19, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R18068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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