Evaluate the Effect of the Strain Lactobacillus PS11610 on the Microbiota of the Female and Male Genital Tract in Couples With Fertility Problems and Dysbiosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Counts of microorganisms presents in cultured samples of genital tracts obtained from infertility couples.
研究概览
简要总结
Pilot study to evaluate the effect of the strain Lactobacillus PS11610 on the microbiota of the female and male genital tract in couples with fertility problems. Couples who have started treatment for artificial insemination or who are on the waiting list for an invitro fertilization treatment will be invited to participate. The estimated duration of the study will be 7 and a half months.
详细描述
Pilot study to evaluate the effect of the strain Lactobacillus PS11610 on the microbiota of the female and male genital tract in couples with fertility problems. Couples who have started treatment for artificial insemination or who are on the waiting list for an invitro fertilization treatment will be invited to participate. The estimated duration of the study will be 7 and a half months.
Four visits are included in the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Couples with ages between 20 and 40
- •Couples under an assisted reproduction treatment: Artificial Insemination or In vitro Fertilization.
- •Signature of informed consent
排除标准
- •Anovulation
- •Hyperprolactinemia
- •Hypogonadotropic hypergonadism
- •Hypergonadotropic Hypergonadism
- •Hyperandrogenisms
- •Polycystic ovary syndrome
- •Endometriosis
- •Pelvic adhesions
- •Myomas, polyps and / or uterine synechia
- •Diagnosis of tubal factor (hydrosalpinx, tubal obstructions)
- •Low ovarian reserve
- •Azoospermia
- •Sperm motility (A + B) <25%
- •Sperm morphology ≤2%
- •With chronic diseases that cause intestinal malabsorption
- •With known congenital or acquired immunodeficiency.
- •Obesity (IMC ≥ 30)
- •Current history or diagnosis of alcohol, tobacco and drug abuse
- •Uncertainty about the willingness or ability of the participants to comply with the requirements of the protocol.
结局指标
主要结局
Counts of microorganisms presents in cultured samples of genital tracts obtained from infertility couples.
时间窗: 7 months and a half
The microbial composition obtained by culture of genital tracts samples from couples with infertility
次要结局
未报告次要终点