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

NCT07187414 | Completed

• 1 other identifier: 2022-06-044-ERAMO0574
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

In Vitro Fertilization (IVF); Medically Assisted Procreation (MAP); intracytoplasmic sperm injection (ICSI); microbiota

Outcome Measures

Primary Outcomes (1)

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

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

  Day 0

Secondary Outcomes (2)

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

  Day 6

• IVF/ICSI success rate

  Day 6

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Collection of data from medical records and analysis of biological samples taken from couples as part of medically assisted procreation care.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé de Parly II

Le Chesnay, 78150, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The samples analyzed come from the bacteria contained in the culture medium

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 23, 2025
• Study Start: January 9, 2024
• Primary Completion: March 29, 2025
• Study Completion: March 29, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)