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

NCT04168567 | Completed

• 1 other identifier: R18068
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

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).

Conditions

Infertility, Female

Keywords

Microbiome; Microbiota; Obesity

Outcome Measures

Primary Outcomes (1)

• Microbiome variety between groups

  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.

  through study completion, 1-2 years from the starting date

Secondary Outcomes (1)

• Ongoing pregnancy rate

  up to 2-3 months

Study Arms (2)

Obese patients

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

Diagnostic Test: Microbiome analysis

Normal-weight patients

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

Diagnostic Test: Microbiome analysis

Interventions

Microbiome analysis DIAGNOSTIC_TEST

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

Normal-weight patients; Obese patients

Eligibility Criteria

• Age: 20 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Obese and non-obese female with male-infertility

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University Hospital

Tampere, Finland

Location

MeSH Terms

Conditions

Infertility, Female; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Katja Ahinko

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: November 19, 2019
• Study Start: August 14, 2020
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

FI (1)