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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04168567

Enrollment

Registered

2019-11-19

Start date

2020-08-14

Completion date

2023-09-01

Last updated

2025-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Female

Keywords

Microbiome, Microbiota, Obesity

Brief 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).

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.

Interventions

DIAGNOSTIC_TESTMicrobiome analysis

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

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 42 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Microbiome variety between groups	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

Measure	Time frame	Description
Ongoing pregnancy rate	up to 2-3 months	Ongoing pregnancy rate

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026