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

Not Applicable

Completed

• Conditions: Fertility Issues
• Interventions: Dietary Supplement: Probiotic Lactobacillus crispatus M247

• Registration Number: NCT05871242
• Lead Sponsor: Dr. Amjad Khan

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 Timeline

• Study Start: 2020-01-10
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-30
• Study First Submitted: 2023-05-03
• Study First Submitted QC: 2023-05-12
• Study First Posted: 2023-05-23
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment arm	Probiotic Lactobacillus crispatus M247	Treatment with Lactobacillus crispatus M247

Primary Outcome Measures

Name	Time	Method
Pregnancy	up to 12 months	Rate of pregnancy

Secondary Outcome Measures

Name	Time	Method
Effect on sex hormonal profile	up to 12 months	Change in Free testosterone levels

Trial Locations

Locations (1)

ART center, Hospital of Conegliano; 🇮🇹 Treviso, Italy