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

NCT ID: NCT07187414

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-09
• Study Completion Date: 2025-03-29

Brief Summary

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

Detailed Description

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).

Conditions

In Vitro Fertilization (IVF); Medically Assisted Procreation (MAP)

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Privé de Parly II

Le Chesnay, , France

Countries

France

Other Identifiers

2022-06-044-ERAMO0574

Identifier Type: -

Identifier Source: org_study_id