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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

Primary Purpose

Fertility Issues

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Probiotic Lactobacillus crispatus M247
Sponsored by
Liaquat University of Medical & Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fertility Issues

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • ART center, Hospital of Conegliano

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment arm

Control arm

Arm Description

Treatment with Lactobacillus crispatus M247

No Probiotic treatment

Outcomes

Primary Outcome Measures

Pregnancy
Rate of pregnancy

Secondary Outcome Measures

Effect on sex hormonal profile
change in anti-mullerian hormone levels
Effect on sex hormonal profile
Change in Follicle Stimulating Hormone levels
Effect on sex hormonal profile
Change in Free testosterone levels

Full Information

First Posted
May 3, 2023
Last Updated
May 12, 2023
Sponsor
Liaquat University of Medical & Health Sciences
Collaborators
Treviso Regional Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05871242
Brief Title
Study to Investigate the Treatment Benefit of Probiotic Lactobacillus Crispatus M247 in Women Undergoing Homologous Level 2 Assisted Reproductive Technology (ART) Procedures
Official Title
Study to Investigate the Treatment Benefit of Probiotic Lactobacillus Crispatus M247 in Women Undergoing Homologous Level 2 Assisted Reproductive Technology (ART) Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liaquat University of Medical & Health Sciences
Collaborators
Treviso Regional Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fertility Issues

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
Treatment with Lactobacillus crispatus M247
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
No Probiotic treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic Lactobacillus crispatus M247
Intervention Description
Patient who have received probiotic Lactobacillus crispatus M247
Primary Outcome Measure Information:
Title
Pregnancy
Description
Rate of pregnancy
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Effect on sex hormonal profile
Description
change in anti-mullerian hormone levels
Time Frame
up to 12 months
Title
Effect on sex hormonal profile
Description
Change in Follicle Stimulating Hormone levels
Time Frame
up to 12 months
Title
Effect on sex hormonal profile
Description
Change in Free testosterone levels
Time Frame
up to 12 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The study is applicable only to women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
ART center, Hospital of Conegliano
City
Treviso
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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