NCT05871242

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

May 3, 2023

Last Update Submit

November 8, 2023

Conditions

Fertility Issues

Outcome Measures

Primary Outcomes (1)

  • Pregnancy

    Rate of pregnancy

    up to 12 months

Secondary Outcomes (3)

  • Effect on sex hormonal profile

    up to 12 months

  • Effect on sex hormonal profile

    up to 12 months

  • Effect on sex hormonal profile

    up to 12 months

Study Arms (2)

Treatment arm

EXPERIMENTAL

Treatment with Lactobacillus crispatus M247

Dietary Supplement: Probiotic Lactobacillus crispatus M247

Control arm

NO INTERVENTION

No Probiotic treatment

Interventions

Probiotic Lactobacillus crispatus M247DIETARY_SUPPLEMENT

Patient who have received probiotic Lactobacillus crispatus M247

Treatment arm

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study is applicable only to women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women undergoing homologous level 2 assisted reproductive technology (ART) procedures
  • Cryopreserved oocytes
  • D3 embryos
  • D5 blastulae
  • Age 18-45

You may not qualify if:

  • Presence of submucous uterine myomas.
  • Uterine malformations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ART center, Hospital of Conegliano

Treviso, Italy

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Clinical Biochemistry and Experimental Medicine

Study Record Dates

First Submitted

May 3, 2023

First Posted

May 23, 2023

Study Start

January 10, 2020

Primary Completion

December 31, 2021

Study Completion

June 30, 2022

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations

IT(1)