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.

Tampere University Hospital1 site in 1 country91 target enrollmentAugust 14, 2020

ConditionsInfertility, Female

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infertility, Female
Sponsor: Tampere University Hospital
Enrollment: 91
Locations: 1
Primary Endpoint: Microbiome variety between groups
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 14, 2020

End Date

September 1, 2023

Last Updated

10 months ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Tampere University Hospital

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

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.