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

Tampere University Hospital

Status: Completed

Conditions: Infertility, Female

Treatments: Diagnostic Test: Microbiome analysis

Study type: Observational

Funder types: Other

Identifiers

NCT04168567

R18068

Details and patient eligibility

About

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).

Full 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.

Enrollment: 91 patients

Sex: Female

Ages: 20 to 42 years old

Volunteers: No 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

Trial design

91 participants in 2 patient groups

Obese patients

Description:

Patients with a BMI higher than 30kg/m² will be included in the first group.

Treatment:

Diagnostic Test: Microbiome analysis

Normal-weight patients

Description:

Patients with a BMI under 25 kg/m² will be included in the second group.

Treatment:

Diagnostic Test: Microbiome analysis