Fertility and the Microbiome

Medical University of Graz

Status: Enrolling

Conditions: Asthenozoospermia; Subfertility

Treatments: Dietary Supplement: Probiotics (Omnibiotic (R))

Study type: Observational

Funder types: Other

Identifiers

NCT05328999

Fertilitom

Details and patient eligibility

About

With this study, the investigators want to investigate the microbiome and human papilloma virus (HPV) status of couples with subfertility. The investigators want to gain information about association of female and male microbiome and its impact on fertility. HPV prevalence is high, and its impact on fertility has not been studied intensively. The investigators want to find out whether there is an association between HPV status and subfertility, vaginal and seminal microbiome and HPV status and the prevalence among our subfertile couples.

As part of this study, the investigators will perform a randomized placebo controlled double blind pilot study to investigate the association between altered sperm quality (impaired motility and elevated DNA fragmentation index), the seminal microbiome and whether intake of probiotics alters these parameters.

Full description

Observational study:

The investigators will include 150 couples within 24 months and will take samples of oral, urinary, stool, vaginal, uterine and seminal microbiome and cervical as well as seminal samples for HPV analysis. Further, the investigators will test for other sexually transmittable diseases, hormone status and metabolic status. Time to pregnancy, pregnancy rate and live birth rate will be evaluated.

Placebo controlled double blind randomized controlled trial:

30 subfertile men (Asthenozoospermia, elevated DNA fragmentation index) will be randomized in to two groups: Placebo or Probiotics for 3 months daily. Before and after these 3 months, sperm count microbiome analysis and HPV analysis will be performed to find possible associations with intake of probiotics.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Couples (Males and females) with subfertility, primary or secondary infertility, or recurrent pregnancy loss.

Exclusion criteria

• unable to consent
• diseases or conditions that might impact investigation
• intake of probiotics, antibiotics within last 3 months
• intake of nutritional supplements
• chemo therapy or radiation therapy
• excess alcohol intake
• smoking

Trial design

300 participants in 2 patient groups

Subfertile patients

Description:

Males and females between 18 and 50 years of age with subfertility presenting at the fertility center at the Medical University of Graz.

Subfertile males with elevated DNA fragmentation index and asthenozoospermia

Description:

Males between 18 and 50 years of age with elevated DNA fragmentation index and asthenozoospermia presenting at the fertility center at the Medical University of Graz.

Treatment:

Dietary Supplement: Probiotics (Omnibiotic (R))