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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04168567
• Other study ID #: R18068
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 14, 2020
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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). .

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 (under 26). 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Diagnostic Test:
• Microbiome analysis
Samples from the vagina, endometrium and anus and analyzing microbiome with NGS technique.

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, 1-2 years from the starting date
Secondary	Ongoing pregnancy rate	Ongoing pregnancy rate	up to 2-3 months