Preovulatory Uterine Flushing With Saline as a Treatment for Unexplained Infertility: A Randomised Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Proportion of participants with a live birth resulting from one cycle of treatment
研究概览
简要总结
The purpose of this study is to determine whether preovulatory uterine flushing with physiological saline is effective in the treatment of unexplained infertility.
详细描述
In vitro fertilisation is the only current reasonable treatment for unexplained infertility. Uterine flushing, associated with a five-fold increase in pregnancy when performed preovulatory, has been proposed as a new alternative. This treatment could flush out debris or alter inflammatory factors preventing fertilisation and implantation. The objective of this study is to assess the efficacy of pre-ovulatory uterine flushing with physiological saline for the treatment of unexplained infertility. This study is a randomised controlled trial based on consecutive women aged between 18 and 37 years consulting for unexplained infertility for at least one year. The day of their luteinizing hormone surge, 192 participants will be randomised in two equal groups to either receive 20 millilitres of physiological saline by an intra-uterine catheter or 10 millilitres of saline intravaginally. Investigators will assess relative risk of live birth (primary outcome), as well as pregnancy over one cycle of treatment. Side effects, complications, and acceptability of the intervention will be reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primary or secondary infertility ≥12 months.
- •Diagnosis of unexplained infertility ≤24 months:
- •Anti-Mullerian hormone ≥0.4 ng/mL and/or follicle-stimulating hormone ≤13 IU/L in early follicular phase;
- •regular cycle of 21-35 days,
- •positive ovulation tests, and/or
- •luteal phase serum progesterone ≥25mmol/L in a natural cycle;
- •semen analysis with total motile sperm count ≥ 5 million;
- •normal uterine cavity;
- •patent tubes.
- •Negative genitourinary test for gonorrhoea and chlamydia ≤12 months.
排除标准
- •Body mass index ≥35 kg/m
- •Ongoing pregnancy.
结局指标
主要结局
Proportion of participants with a live birth resulting from one cycle of treatment
时间窗: 10 months after randomisation
Proportion of participants with a live birth resulting from one cycle of treatment based on questionnaire and medical data.
次要结局
- Adverse effects(One month after randomisation)
- Proportion of participants with a pregnancy resulting from one cycle of treatment(One month after randomisation)
- Proportion of participants who find the intervention acceptable(One month after randomisation)