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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05871242
Other study ID # LUMHS/REC/-253
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2020
Est. completion date June 30, 2022

Study information

Verified date November 2023
Source Liaquat University of Medical & Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date June 30, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Probiotic Lactobacillus crispatus M247
Patient who have received probiotic Lactobacillus crispatus M247

Locations

Country Name City State
Italy ART center, Hospital of Conegliano Treviso

Sponsors (2)

Lead Sponsor Collaborator
Dr. Amjad Khan Treviso Regional Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pregnancy Rate of pregnancy up to 12 months
Secondary Effect on sex hormonal profile change in anti-mullerian hormone levels up to 12 months
Secondary Effect on sex hormonal profile Change in Follicle Stimulating Hormone levels up to 12 months
Secondary Effect on sex hormonal profile Change in Free testosterone levels up to 12 months
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