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Clinical Trials/NCT05871242
NCT05871242CompletedNot Applicable

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

Dr. Amjad Khan1 site in 1 country160 target enrollmentStarted: January 10, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
160
Locations
1
Primary Endpoint
Pregnancy
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
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.

Outcomes

Primary Outcomes

Pregnancy

Time Frame: up to 12 months

Rate of pregnancy

Secondary Outcomes

  • Effect on sex hormonal profile(up to 12 months)

Investigators

Sponsor
Dr. Amjad Khan
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Dr. Amjad Khan

Professor of Clinical Biochemistry and Experimental Medicine

Liaquat University of Medical & Health Sciences

Study Sites (1)

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Study to Investigate the Treatment Benefit... | Clinical Trial