In Vitro Fertilization (IVF)SPERMIBIOTENCT07187414
Microbiological Description of Sperm and Follicular Fluid Samples. Impact on IVF/ICSI Success Rates
An observational study of In Vitro Fertilization (IVF) and Medically Assisted Procreation (MAP), run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- In Vitro Fertilization (IVF), Medically Assisted Procreation (MAP)
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2024to 29 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Study population: Collection of data from medical records and analysis of biological samples taken from couples as part of medically assisted procreation care.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microbiological Description of Sperm and Follicular Fluid Samples. Impact on IVF/ICSI Success Rates (SPERMIBIOTE)
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
Read the 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).
- Keywords
- In Vitro Fertilization (IVF), Medically Assisted Procreation (MAP), intracytoplasmic sperm injection (ICSI), microbiota
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Description: Analysis of sequences of bacteria identified by amplification and sequencing of the gene encoding 16S rRNA in aliquots taken on day 6.
Measured: Day 6
IVF/ICSI success rate
presence of a morula on day 6
Measured: Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start9 Jan 2024
- Primary completion29 Mar 2025
- Study completion29 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Vitro Fertilization (IVF)Studies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187414
- Sponsor's protocol ID
- 2022-06-044-ERAMO0574
- Acronym
- SPERMIBIOTE
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiological Description of Sperm and Follicular Fluid Samples. Impact on IVF/ICSI Success Rates (SPERMIBIOTE)
- ClinicalTrials.gov ID
- NCT07187414
- Acronym / sponsor ID
- SPERMIBIOTE / 2022-06-044-ERAMO0574
- Keywords
- In Vitro Fertilization (IVF), Medically Assisted Procreation (MAP), intracytoplasmic sperm injection (ICSI), microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 29 Mar 2025 (actual)
- Study completion
- 29 Mar 2025 (actual)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Collection of data from medical records and analysis of biological samples taken from couples as part of medically assisted procreation care.
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
IVF/ICSI success rate
Time frame: Day 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of In Vitro Fertilization (IVF) and Medically Assisted Procreation (MAP), run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification and identification of bacteria present in semen and follicular fluid samples on the day of the IVF-ICSI attempt. (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.