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

NCT ID: NCT04168567

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-14

Study Completion Date

2023-09-01

Brief Summary

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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

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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.

Conditions

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Infertility, Female

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Obese patients

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

Microbiome analysis

Intervention Type DIAGNOSTIC_TEST

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

Normal-weight patients

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

Microbiome analysis

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Microbiome analysis

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katja Ahinko

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

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Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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R18068

Identifier Type: -

Identifier Source: org_study_id

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