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

NCT ID: NCT05871242

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-10

Study Completion Date

2022-06-30

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.

Conditions

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Fertility Issues

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment arm

Treatment with Lactobacillus crispatus M247

Group Type EXPERIMENTAL

Probiotic Lactobacillus crispatus M247

Intervention Type DIETARY_SUPPLEMENT

Patient who have received probiotic Lactobacillus crispatus M247

Control arm

No Probiotic treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Probiotic Lactobacillus crispatus M247

Patient who have received probiotic Lactobacillus crispatus M247

Intervention Type DIETARY_SUPPLEMENT

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Treviso Regional Hospital

NETWORK

Sponsor Role collaborator

Dr. Amjad Khan

OTHER

Sponsor Role lead

Responsible Party

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Dr. Amjad Khan

Professor of Clinical Biochemistry and Experimental Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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ART center, Hospital of Conegliano

Treviso, , Italy

Site Status

Countries

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Italy

Other Identifiers

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LUMHS/REC/-253

Identifier Type: -

Identifier Source: org_study_id

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