Skip to main content
OpenTrials
Completed

NCT Number: NCT07187414

Microbiological Description of Sperm and Follicular Fluid Samples. Impact on IVF/ICSI Success Rates

The goal of this observational study is to quantify and identify bacteria that may be present in semen and follicular fluid samples on the day of the IVF-ICSI attempt.

The secondary objective is to :

* Quantify and identify bacteria that may be present in embryo culture media on day 6. * Correlate microbiological analyses of sperm and follicular fluids with those of embryo culture media on day 6. * Evaluate their impact on fertilization and blastulation rates

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Privé de Parly II

Le Chesnay, 78150, France

About this study

This is a single-center observational study based on data contained in the medical records of couples treated and evaluated as part of Medically Assisted Procreation (IVF-ICSI).

This study was conducted at the Parly 2 private hospital for data and sample collection, at the Parly 2 hospital microbiology laboratory, and at Life & Soft Fontenay-aux-Roses for sample analysis.

Collected samples will not be stored after analysis. The objective of this study does not impose any particular constraints. The study consists of a single assessment, the data from which will be recorded on an electronic case report form (CRF).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Man aged 18 to 59 who have provided a sperm sample after an abstinence period of between 2 and 7 days. Sperm prepared by density gradient on day 0. Negative sperm culture (<6 months). No specific urogenital history (varicocele, cryptorchidism, testicular ectopia, etc.).
  • Women aged 18 to 43 undergoing oocyte puncture with collection of follicular fluid on day 0. No endometriosis or hydrosalpinx. Negative vaginal sample (< 6 months).
  • Negative HIV, HBV, and HCV serology tests within the last year.
  • Absence of urinary tract infections in men and sexually transmitted infections (HPV, HSV, HIV-1/2, C. trachomatis, Gonorrhea, Syphilis, etc.) (<6 months).
  • Absence of recent antibiotic or antifungal treatment (end of treatment < 3 months) Absence of probiotic intake (< 3 months).
  • No history of chemotherapy or radiation therapy.
  • Embryonic culture performed up to day 6 for all zygotes.

Exclusion criteria

  • Homosexual patient couples or transsexual couples
  • Patients treated for medically assisted procreation with a third-party donor
  • Frozen sperm pellets (ejaculate or surgical)
  • Donor sperm
  • Sperm prepared by washing
  • Abstinence period <2 or >7 days
  • Fever <3 months
  • History of chemotherapy or radiotherapy.
  • History of urinary tract infections in man (< 6 months)
  • History of sexually transmitted infections (HPV, HSV, HIV-1/2, C. trachomatis, gonorrhea, syphilis, etc.) (<6 months)
  • Specific urogenital history (varicocele, cryptorchidism, testicular ectopia, etc.)
  • Recent antibiotic therapy or antifungal treatment (end of treatment < 3 months)
  • Taking probiotics (end of treatment < 3 months)
  • Positive sperm culture < 6 months.
  • Positive vaginal sample < 6 months. White puncture.
  • Collection failure.
  • Fertilization failure

Treatment and study plan

Primary outcomes

  1. Quantification and identification of bacteria present in semen and follicular fluid samples on the day of the IVF-ICSI attempt.

    Time frame: Day 0

    Analysis of sequences of bacteria identified by amplification and sequencing of the gene encoding 16S rRNA in aliquots taken on day 0.

Secondary outcomes

  1. Quantification and identification of bacteria present in semen and follicular fluid samples on the day 6 after of the IVF-ICSI attempt.

    Time frame: Day 6

    Description: Analysis of sequences of bacteria identified by amplification and sequencing of the gene encoding 16S rRNA in aliquots taken on day 6.

  2. IVF/ICSI success rate

    Time frame: Day 6

    presence of a morula on day 6

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

Microbiological Description of Sperm and Follicular Fluid Samples. Impact on IVF/ICSI Success Rates (SPERMIBIOTE)

Acronym: SPERMIBIOTE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2025
Registry last updated
Sep 23, 2025

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.

Published trials that share one or more normalized conditions with this study.