CompletedNot Applicable

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

France50 participantsStarted 2024-01-09

Plain-language 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

Who can participate

Age range

18 Years – 59 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, cryptorchid…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Day 0

Trial details

NCT IDNCT07187414

SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-29

View on ClinicalTrials.gov More In Vitro Fertilization (IVF) trials