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Completed

NCT Number: NCT05871242

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

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.

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Key information

Conditions

Fertility Issues Genital Diseases Infertility Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ART center, Hospital of Conegliano

Treviso, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic Lactobacillus crispatus M247

Dietary Supplement

Patient who have received probiotic Lactobacillus crispatus M247

Primary outcomes

  1. Pregnancy

    Time frame: up to 12 months

    Rate of pregnancy

Secondary outcomes

  1. Effect on sex hormonal profile

    Time frame: up to 12 months

    change in anti-mullerian hormone levels

  2. Effect on sex hormonal profile

    Time frame: up to 12 months

    Change in Follicle Stimulating Hormone levels

  3. Effect on sex hormonal profile

    Time frame: up to 12 months

    Change in Free testosterone levels

Sponsors and collaborators

Lead sponsor

Dr. Amjad Khan

Other

Collaborators

  • Treviso Regional Hospital

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
May 23, 2023
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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