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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

Sponsor
Liaquat University of Medical & Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT05871242
Collaborator
Treviso Regional Hospital (Other)
160
Enrollment
1
Location
2
Arms
29.6
Actual Duration (Months)
5.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Probiotic Lactobacillus crispatus M247
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
160 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Study to Investigate the Treatment Benefit of Probiotic Lactobacillus Crispatus M247 in Women Undergoing Homologous Level 2 Assisted Reproductive Technology (ART) Procedures
Actual Study Start Date :
Jan 10, 2020
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment arm

Treatment with Lactobacillus crispatus M247

Dietary Supplement: Probiotic Lactobacillus crispatus M247
Patient who have received probiotic Lactobacillus crispatus M247
No Intervention: Control arm

No Probiotic treatment

Outcome Measures

Primary Outcome Measures

  1. Pregnancy [up to 12 months]

    Rate of pregnancy

Secondary Outcome Measures

  1. Effect on sex hormonal profile [up to 12 months]

    change in anti-mullerian hormone levels

  2. Effect on sex hormonal profile [up to 12 months]

    Change in Follicle Stimulating Hormone levels

  3. Effect on sex hormonal profile [up to 12 months]

    Change in Free testosterone levels

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 ART center, Hospital of Conegliano Treviso Italy

Sponsors and Collaborators

  • Liaquat University of Medical & Health Sciences
  • Treviso Regional Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Amjad Khan, Professor of Clinical Biochemistry and Experimental Medicine, Liaquat University of Medical & Health Sciences
ClinicalTrials.gov Identifier:
NCT05871242
Other Study ID Numbers:
  • LUMHS/REC/-253
First Posted:
May 23, 2023
Last Update Posted:
May 23, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infertility

Study Results

No Results Posted as of May 23, 2023