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

Dr. Amjad Khan

Status: Completed

Conditions: Fertility Issues

Treatments: Dietary Supplement: Probiotic Lactobacillus crispatus M247

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT05871242

LUMHS/REC/-253

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Treatment arm

Experimental group

Description:

Treatment with Lactobacillus crispatus M247

Treatment:

Dietary Supplement: Probiotic Lactobacillus crispatus M247

Control arm

No Intervention group

Description:

No Probiotic treatment