Vaginal Microbiome Influence on the Results of Assisted Reproduction Techniques
Condition: Implantation Failure
Study type: Interventional

Summary: 
      The objective of the present study to analyze the vaginal microbiome in patients who have not
      achieved gestation after oocyte donation treatment and after probiotic administration.

      All patients will receive vaginal probiotic according to the standard regimen. Sample
      collection will be performed the embryo transfer day and on the day of the pregnancy test.
      Follow up of gestation will be carried out.

      The analysis of the vaginal microbiome will be performed though massive genetic sequencing
      (determination of 16SRNA).

      The study variables, among others, are vaginal microbiome pattern after probiotic
      administration, the gestation rate, and the abortion rate.
    

Detailed description: 
      This study will be performed after the observational study "Vaginal microbiome influence on
      the results of assisted reproduction techniques". The main goal of this previous study will
      be to identify patterns of vaginal and / or endometrial microbiome in relation to the
      gestation rate in women with implantation failure and / or repeat abortions who undergo an
      oocyte donation treatment. The vaginal and endometrial microbiome of women with (i)
      implantation failure, (ii) repeat abortions and (iii) control group without implantation
      failure or repeat abortions, will be analyzed before and after the embryo transfer.

      Those women who do not achieve pregnancy will be eligible for the present study. The
      objective of the present study to analyze the vaginal microbiome in patients who have not
      achieved gestation after oocyte donation treatment and after probiotic administration.

      All patients will receive vaginal probiotic according to the standard regimen: 1 tablet (via
      vaginal) for 5 days after menstruation during the same cycle of the next embryo transfer.

      The vaginal sample will be analyzed after taking the probiotic. Sample collection will be
      performed the embryo transfer day and on the day of the pregnancy test. Follow up of
      gestation will be carried out.

      Vaginal sample collection: obtention of vaginal fluid with vaginal swab by direct
      visualization. Direct visualization means having the patient in a lithotomy position, like a
      routine gynecological examination by visualization with a vaginal speculum.

      The analysis of the vaginal microbiome will be performed though massive genetic sequencing
      (determination of 16SRNA). First of all, the extraction of RNA and subsequent analysis. We
      will analyze the groups of microorganisms, as well as the determination of patterns related
      to failure of implantation, repetitive abortions and gestation success.

      The study variables, among others, are vaginal microbiome pattern after probiotic
      administration, the gestation rate, and the abortion rate. The vaginal microbiome will be
      compared with the results of the previous observational study.
    

Intervention name(s): Probiotic
Intervention type(s): Other
Intervention description(s): Vaginal probiotic administration according to the standard regimen: 1 tablet (via vaginal) for 5 days after menstruation during the same cycle of the next embryo transfer.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: implantation failure; fertility; microbiome; Assisted reproduction