Study to Investigate the Treatment Benefit of Probiotic Lactobacillus Crispatus M247 in Women Undergoing Homologous Level 2 Assisted Reproductive Technology (ART) Procedures

Study Overview
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Brief Summary
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The present study is aimed to explore the treatment effect from the intake of probiotic Lactobacillus crispatus M247 in the improvement of clinical and psychological aspects in women undergoing homologous level 2 ART procedures.

Detailed Description
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The use of assisted reproductive technology (ART) has increased dramatically worldwide due to the continuous rise in infertility rates; for these reasons an increasing number of couples undertake the path of ART, even though this is difficult journey, with uncertain outcomes and possible medical risks, both physical and psychological. In this study the investigators aim to explore the hypothesis that recreating a favorable vaginotype through the intake of the probiotic Lactobacillus crispatus M247 can have a positive effect in achieving pregnancy in cryopreserved cycles as well as a positive relationship between vaginal, endometrial (still unknown), gut and oral microbiota.

Official Title
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Study to Investigate the Treatment Benefit of Probiotic Lactobacillus Crispatus M247 in Women Undergoing Homologous Level 2 Assisted Reproductive Technology (ART) Procedures

Conditions
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Fertility Issues

Intervention / Treatment
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* Dietary Supplement: Probiotic Lactobacillus crispatus M247


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women undergoing homologous level 2 assisted reproductive technology (ART) procedures Cryopreserved oocytes D3 embryos D5 blastulae Age 18-45 Exclusion Criteria: Presence of submucous uterine myomas. Uterine malformations.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>Treatment with Lactobacillus crispatus M247 | Dietary Supplement: Probiotic Lactobacillus crispatus M247<br>* Patient who have received probiotic Lactobacillus crispatus M247<br>|
| No Intervention: Control arm<br>No Probiotic treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy | Rate of pregnancy | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on sex hormonal profile | change in anti-mullerian hormone levels | up to 12 months | 
| Effect on sex hormonal profile | Change in Follicle Stimulating Hormone levels | up to 12 months | 
| Effect on sex hormonal profile | Change in Free testosterone levels | up to 12 months |