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

Fertility Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05871242
• Other study ID #: LUMHS/REC/-253
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Fertility Issues
• Infertility

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