ACTRN12619001003167进行中(未招募)未知
Effect of IVF compared to Intrauterine Insemination on live birth rate in couples with uneXplained infertility (The FIIX Study).
niversity of Auckland0 个研究点目标入组 737 人开始时间: 2019年7月15日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 737
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 54 Years(—)
- 性别
- All
入选标准
- •Inclusion criteria
- •1. Eligible for two packages of publicly funded fertility treatment in NZ and all of the following:
- •a. Age - Female <39 years 4 months and male <54 years and 4months at the time of randomisation.
- •b. Body mass index (BMI) - Female - BMI < /= 32.
- •c. Both partners are non-smokers for three months.
- •d. Both partners with no history of illicit drug use or alcohol abuse within the preceding 12 months.
- •e. Day 2 FSH <15IU for the female partner
- •f. Both partners must be a NZ citizen or resident, hold a NZ work visa or student visa which allows them to stay in NZ continuously for two years or more, or be an Australian citizen or resident who can prove intention to stay in NZ for two years or more.
- •g. Couples must have:
- •i. No previous children from public fertility treatment.
- •ii. No more than one child (including adopted children) of any age to the same relationship, or
- •iii. No more than one child from a previous relationship living at home (at least half of the time)
- •2. Female partner has a regular ovulatory cycle (21-35 days).
- •3. Female partner has evidence of patent fallopian tube(s) on hysterosalpingogram or at laparoscopy or recent intrauterine miscarriage (within 24 months) (tubal spasm is not considered tubal blockage).
- •4. Male partner has a total motile sperm count (TMSC) > 10 million, on last semen analysis or within two of the past three semen analyses.
排除标准
- •1. Women with a history of stage 3 and 4 endometriosis
- •2. Women with submucosal fibroids or any fibroid >8cm or fibroids between 5-8cm if endometrial cavity is distorted or cavity length is >10cm.
- •3. Couple who require egg or sperm donation
- •4. Women with a past history of ectopic pregnancy or bilateral blocked tubes or tubal surgery for adhesions/hydrosalpinges.
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