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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05871242
Enrollment
160
Registered
2023-05-23
Start date
2020-01-10
Completion date
2022-06-30
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fertility Issues

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTProbiotic Lactobacillus crispatus M247

Patient who have received probiotic Lactobacillus crispatus M247

Sponsors

Treviso Regional Hospital
CollaboratorNETWORK
Dr. Amjad Khan
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pregnancyup to 12 monthsRate of pregnancy

Secondary

MeasureTime frameDescription
Effect on sex hormonal profileup to 12 monthschange in anti-mullerian hormone levels

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026