ChiCTR-IIC-16010249尚未招募Unknown
高能量聚焦式超音波（HIFU)治療無排卵性不孕的卵巢多囊症婦女之劑量研究
未提供1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 1990年1月1日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To prospectively evaluate the feasibility and efficacy of HIFU in inducing ovulation in PCOS women.
研究概览
简要总结
高能量聚焦式超音波（HIFU)治療無排卵性不孕的卵巢多囊症婦女之劑量
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 40（—）
- 性别
- Female
入选标准
- •Premenopausal women aged 18 to 40 years diagnosed with PCOS with anovulatory infertility;
- •Ability to give informed consent;
- •Body mass index <30 kg/m2;
- •Not on hormonal therapy (GnRH or combined oral contraceptive pills - COC) at the time of HIFU treatment;
- •No previous history of laparoscopic ovarian drilling or ovarian surgery;
- •Women with patent bilateral tubes;
- •Failure to achieve ovulation or pregnancy with incremental doses of clomiphene citrate;
- •Ability to give communicate clearly with a nurse or physician during HIFU treatment;
- •Women willing and able to comply with study requirements.
排除标准
- •Pre-existing thyroid problem or hyperprolactinaemia which may cause anovulation;
- •Those with pre-existing compromised ovarian failure as evident by day 2 FSH >10IU/L or an AMH value of <0.75ng/ml before the treatment;
- •Pregnant or lactating;
- •Presence of active pelvic inflammatory disease, genital or extra-genital malignancy;
- •Extensive scarring along anterior lower abdominal wall (greater than 50% of area) or scar tissue or surgical clips in the direct path of the HIFU;
- •Unable to give consent or those who are unable for regular follow- ups after the study;
- •Those with an intrauterine device in situ;
- •Those with tattoos or metalic implants over their abdomen;
- •Male partner with moderate to severe male factor.
研究组 & 干预措施
Case series
All sonographically guided HIFU procedures will be performed with the same HIFU system (HIFU-2001; SJTU Suntec Industry, Shanghai, China)
结局指标
主要结局
To prospectively evaluate the feasibility and efficacy of HIFU in inducing ovulation in PCOS women.
次要结局
- To determine the acute, medium-term and long-term endocrine changes after HIFU and compare the changes to those reported after LOD.(for follow-up daily for 5 days after the procedure, weekly for 6 weeks then at 6 months after HIFU)
- To determine the lowest effective dose of ultrasound energy used during HIFU in the induction of ovulation in women with PCOS.(for follow-up daily for 5 days after the procedure, weekly for 6 weeks then at 6 months after HIFU)
- To determine the safety of HIFU in the treatment of PCOS, including the possible risk of compromised ovarian function.(for follow-up daily for 5 days after the procedure, weekly for 6 weeks then at 6 months after HIFU)
研究者
研究点 (1)
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