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

Primary Purpose

Infertility, Female

Status

Active

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Microbiome analysis

About this trial

This is an interventional diagnostic trial for Infertility, Female focused on measuring Microbiome, Microbiota, Obesity

Eligibility Criteria

20 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Tampere University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Obese patients

Normal weight patients

Arm Description

Patients who have BMI higher than 30

Patients who have BMI between 20 and 25.

Outcomes

Primary Outcome Measures

Microbiome variety between groups

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.

Secondary Outcome Measures

Ongoing pregnancy rate

Full Information

NCT ID

NCT04168567

First Posted

September 19, 2019

Last Updated

March 23, 2023

Sponsor

Tampere University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04168567

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 14, 2020 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tampere University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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). .

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility, Female

Keywords

Microbiome, Microbiota, Obesity

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Obese patients

Arm Type

Experimental

Arm Description

Patients who have BMI higher than 30

Arm Title

Normal weight patients

Arm Type

Experimental

Arm Description

Patients who have BMI between 20 and 25.

Intervention Type

Diagnostic Test

Intervention Name(s)

Microbiome analysis

Intervention Description

Samples from the vagina, endometrium and anus and analyzing microbiome with NGS technique.

Primary Outcome Measure Information:

Title

Microbiome variety between groups

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Ongoing pregnancy rate

Description

Ongoing pregnancy rate

Time Frame

up to 2-3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

42 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Katja Ahinko

Organizational Affiliation

Tampere University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tampere University Hospital

City

Tampere

Country

Finland

12. IPD Sharing Statement

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

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