Microbiological Description of Sperm and Follicular Fluid Samples. Impact on IVF/ICSI Success Rates (SPERMIBIOTE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Quantification and identification of bacteria present in semen and follicular fluid samples on the day of the IVF-ICSI attempt.
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
- •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.
排除标准
- •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
结局指标
主要结局
Quantification and identification of bacteria present in semen and follicular fluid samples on the day of the IVF-ICSI attempt.
时间窗: Day 0
Analysis of sequences of bacteria identified by amplification and sequencing of the gene encoding 16S rRNA in aliquots taken on day 0.
次要结局
- 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)