Modulation of the Reproductive Microbiota as a Strategy to Increase Rates of Reproductive Success in Couples With Infertility of Unknown Origin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 6
- 主要终点
- Successful pregnancies
研究概览
简要总结
The objective of the project is to elucidate if the oral administration of Ligilactobacillus salivarius CECT5713 is capable of improving the rates of term pregnancies in couples with infertility problems of unknown cause. On the other hand, the project is aimed to detect microbiological, immunological and hormonal markers that allow the identification of couples in which the administration of the strain could be particularly effective. This is a randomized, double-blind, parallel-group controlled nutritional intervention study. The intervention (Ligilactobacillus salivarius CECT5713 or placebo) will be performed during the 6 months prior to the fertility treatment and during the first IVF cycle (estimated 1-2 months). In case of pregnancy, the woman will continue the treatment until 12 weeks of gestation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Triple (Participant, Care Provider, Investigator) Only one person of the collaborator that provides the capsules (Biosearch Life) know the correspondecs between each reference (one reference per each subject) and the arm (probiotic or placebo). The codes are blinded for the participant, the care provider and the investigator.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •legal age
- •Intention to achieve a pregnancy, but without achieving it;
- •Be willing to undergo in vitro fertilization treatment;
- •Be on the waiting list for the IVF cycle with an expected waiting time > 5 months.
排除标准
- •Sterility in one of the members of the couple (azoospermia; impermeability of the fallopian tubes...).
- •Genitourinary malformations;
- •Concurrence of other severe diseases (e.g.: cancer, AIDS, ALS, morbid obesity...) or uncontrolled diseases (inflammatory bowel diseases, diabetes...).
- •Treatment/intervention other than the planned IVF after the start date of the intervention.
- •Antibiotic treatment at the start date of the intervention.
- •Intention to consume another probiotic supplement in the following 3 months.
- •Participation in another clinical trial.
- •Allergic/intolerant to the excipient.
- •Inability to understand the informed consent form and/or to follow the basic instructions of the trial.
结局指标
主要结局
Successful pregnancies
时间窗: 9 months
Total number of pregnancies with delivery of a healthy baby
次要结局
- Vaginal immunomodulation(9 months)
- Modification of the vaginal microbiota(9 months)