The Impact of Body Mass Index in the Endometrial Microbiome in IVF Treatments

March 23, 2023 updated by: Tampere University Hospital

A Protocol for a Prospective Study to Compare Endometrial Microbiome in Patients Having Body Mass Index Over 30 Versus 20-25

This study is a prospective trial with 90 patients suffering from the male type infertility. Patients are divided in two groups (45 patients per group) on the grounds of body mass index (BMI). .

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is going to clarify endometrial, vaginal and anal microbiome variety between obese and normal weight patients. In the first group, the body mass index (BMI) of patients will be higher than 30 and in the other group, patients will be in their normal weight BMI 20-25. The samples are going to be examined in the time of the embryo transfer and microbiome will be analyzed in laboratory specialized in NGS techniques.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with male infertility and scheduled IVF treatment and fresh embryo transfer
  • Primary or secondary male type infertility
  • BMI over 30 kg/m2 or 20-25 kg/m2
  • Patient's willingness to participate

Exclusion Criteria:

  • Patients with endometriosis or adenomyosis
  • Antibiotics during IVF treatment or ovum pick-up
  • Technical diffuculties in embryo transfer or no embryos to transfer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Obese patients
Patients who have BMI higher than 30
Diagnostic test: Microbiome analysis
Samples from the vagina, endometrium and anus and analyzing microbiome with NGS technique.
Experimental: Normal weight patients
Patients who have BMI between 20 and 25.
Diagnostic test: Microbiome analysis
Samples from the vagina, endometrium and anus and analyzing microbiome with NGS technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiome variety between groups
Time Frame: through study completion, 1-2 years from the starting date
Differences in endometrial, vaginal and anal microbiome between obese and normal weight patients. Sample will be taken at the moment of embryo transfer with embryo catheter.
through study completion, 1-2 years from the starting date

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy rate
Time Frame: up to 2-3 months
Ongoing pregnancy rate
up to 2-3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2020

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

September 19, 2019

First Submitted That Met QC Criteria

November 18, 2019

First Posted (Actual)

November 19, 2019

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R18068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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