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

Not Applicable

Completed

• Conditions: Infertility, Female
• Interventions: Diagnostic Test: Microbiome analysis

• Registration Number: NCT04168567
• Lead Sponsor: Tampere University Hospital

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 endometrial, vaginal and anal microbiome variety between obese and healthy-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 20-25 (under 26). The samples will be collected at the time of embryo transfer and analyzed in a laboratory specialing in next-geration sequencing (NGS) techniques.

Study Timeline

• Study First Submitted: 2019-09-19
• Study First Submitted QC: 2019-11-18
• Study First Posted: 2019-11-19
• Study Start: 2020-08-14
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 91

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 between 20-25 kg/m² (under 26)
• 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal weight patients	Microbiome analysis	Patients who have BMI between 20 and 25.
Obese patients	Microbiome analysis	Patients who have BMI higher than 30

Primary Outcome Measures

Name	Time	Method
Microbiome variety between groups	through study completion, 1-2 years from the starting date	This study aims to investigate differences and continuum in endometrial, vaginal and anal microbiome 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 Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	up to 2-3 months	Ongoing pregnancy rate

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland