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

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).

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Key information

Conditions

Infertility, Female Body Weight Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases

Age range

20 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

Tampere University Hospital

Tampere, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microbiome analysis

Diagnostic Test

Samples from TIMP microbiome project will be analyzed with NGS techniques.

Primary outcomes

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.

Secondary outcomes

Ongoing pregnancy rate

Time frame: up to 2-3 months

Ongoing pregnancy rate

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study 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.

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Nov 19, 2019
Registry last updated: Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed