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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility, Female

Intervention / Treatment
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* Diagnostic Test: Microbiome analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiome, Microbiota, Obesity