Background: Intrauterine insemination with controlled ovarian hyperstimulation is commonly used as first-line treatment for couples with unexplained subfertility. Since such treatment increases the risk of multiple pr...Background: Intrauterine insemination with controlled ovarian hyperstimulation is commonly used as first-line treatment for couples with unexplained subfertility. Since such treatment increases the risk of multiple pregnancy, a couple’s chances of achieving an ongoing pregnancy without it should be considered to identify those most likely to benefit from treatment. We aimed to assess the incremental effectiveness of intrauterine insemination with controlled ovarian hyperstimulation compared with expectant management in couples with unexplained subfertility and an intermediate prognosis of a spontaneous ongoing pregnancy. Methods: 253 couples with unexplained subfertility and a 30- 40% probability of a spontaneous ongoing pregnancy within 12 months were randomly assigned either intrauterine insemination with controlled ovarian hyperstimulation for 6 months or expectant management for 6 months. The primary endpoint of this hospital-based study was ongoing pregnancy within 6 months. Analysis was by intention to treat. This trial is registered with the Dutch Trial Register and as an International Standard Randomised Clinical Trial, number ISRCTN72675518. Findings: Of the 253 couples enrolled, 127 were assigned intrauterine insemination with controlled ovarian hyperstimulation and 126 expectant management. In the intervention group, 42 (33% ) women conceived and 29 (23% ) pregnancies were ongoing. In the expectant management group, 40 (32% ) women conceived and 34 (27% ) pregnancies were ongoing (relative risk 0.85, 95% CI 0.63- 1.1). There was one twin pregnancy in each study group, and one woman in the intervention group conceived triplets. Interpretation: A large beneficial effect of intrauterine insemination with controlled ovarian hyperstimulation in couples with unexplained subfertility and an intermediate prognosis can be excluded. Expectant management for 6 months is therefore justified in these couples.展开更多
一、临床试验的发展过程 有关临床试验的最早记载可追溯到十八世纪。1947年Sir James Lind为寻找治疗坏血病的有效方法,将患者分为6组,每组2人,分别给予苹果汁、硫酸酏剂、醋,海水、桔子、柠檬和肉豆蔻治疗。结果,服用桔子与柠檬的2位...一、临床试验的发展过程 有关临床试验的最早记载可追溯到十八世纪。1947年Sir James Lind为寻找治疗坏血病的有效方法,将患者分为6组,每组2人,分别给予苹果汁、硫酸酏剂、醋,海水、桔子、柠檬和肉豆蔻治疗。结果,服用桔子与柠檬的2位病人很快痊愈,其他病人无好转,说明柑桔类水果可治疗坏血病。1935年Lonald Fisher首次用随机方法进行试验分组应用于农业研究。第二次世界大战以后。展开更多
Objective: To compare the outcome of day 2 and day 3 embryo transfers in women demonstrating poor ovarian response. Design: Prospective randomized clinical trial. Setting: Private assisted reproductive technology cent...Objective: To compare the outcome of day 2 and day 3 embryo transfers in women demonstrating poor ovarian response. Design: Prospective randomized clinical trial. Setting: Private assisted reproductive technology center. Patient(s): Two hundred eighty-one women demonstrating poor ovarian response to controlled ovarian hyperstimulation. Intervention(s): Women who were poor responders were randomly allocated to day 2 or day 3 embryo transfer following oocyte retrieval. Main Outcome Measure(s): Implantation rates and pregnancy rates per oocyte retrieval and embryo transfer. Result(s): The clinical pregnancy rates per oocyte retrieval (37.2% vs. 21.4% , respectively; P < .05) and per embryo transfer (38.9% vs. 24.1% , respectively; P < .05) were significantly higher in the day 2 embryo transfer group compared with day 3. On the other hand, implantation rates were not different between groups (23.9% vs. 17.2% , respectively; P = .08). Conclusion(s): Our results demonstrated that trans-fering embryos on day 2 could provide an alternative to the management of poor responder patients.展开更多
文摘Background: Intrauterine insemination with controlled ovarian hyperstimulation is commonly used as first-line treatment for couples with unexplained subfertility. Since such treatment increases the risk of multiple pregnancy, a couple’s chances of achieving an ongoing pregnancy without it should be considered to identify those most likely to benefit from treatment. We aimed to assess the incremental effectiveness of intrauterine insemination with controlled ovarian hyperstimulation compared with expectant management in couples with unexplained subfertility and an intermediate prognosis of a spontaneous ongoing pregnancy. Methods: 253 couples with unexplained subfertility and a 30- 40% probability of a spontaneous ongoing pregnancy within 12 months were randomly assigned either intrauterine insemination with controlled ovarian hyperstimulation for 6 months or expectant management for 6 months. The primary endpoint of this hospital-based study was ongoing pregnancy within 6 months. Analysis was by intention to treat. This trial is registered with the Dutch Trial Register and as an International Standard Randomised Clinical Trial, number ISRCTN72675518. Findings: Of the 253 couples enrolled, 127 were assigned intrauterine insemination with controlled ovarian hyperstimulation and 126 expectant management. In the intervention group, 42 (33% ) women conceived and 29 (23% ) pregnancies were ongoing. In the expectant management group, 40 (32% ) women conceived and 34 (27% ) pregnancies were ongoing (relative risk 0.85, 95% CI 0.63- 1.1). There was one twin pregnancy in each study group, and one woman in the intervention group conceived triplets. Interpretation: A large beneficial effect of intrauterine insemination with controlled ovarian hyperstimulation in couples with unexplained subfertility and an intermediate prognosis can be excluded. Expectant management for 6 months is therefore justified in these couples.
文摘一、临床试验的发展过程 有关临床试验的最早记载可追溯到十八世纪。1947年Sir James Lind为寻找治疗坏血病的有效方法,将患者分为6组,每组2人,分别给予苹果汁、硫酸酏剂、醋,海水、桔子、柠檬和肉豆蔻治疗。结果,服用桔子与柠檬的2位病人很快痊愈,其他病人无好转,说明柑桔类水果可治疗坏血病。1935年Lonald Fisher首次用随机方法进行试验分组应用于农业研究。第二次世界大战以后。
文摘Objective: To compare the outcome of day 2 and day 3 embryo transfers in women demonstrating poor ovarian response. Design: Prospective randomized clinical trial. Setting: Private assisted reproductive technology center. Patient(s): Two hundred eighty-one women demonstrating poor ovarian response to controlled ovarian hyperstimulation. Intervention(s): Women who were poor responders were randomly allocated to day 2 or day 3 embryo transfer following oocyte retrieval. Main Outcome Measure(s): Implantation rates and pregnancy rates per oocyte retrieval and embryo transfer. Result(s): The clinical pregnancy rates per oocyte retrieval (37.2% vs. 21.4% , respectively; P < .05) and per embryo transfer (38.9% vs. 24.1% , respectively; P < .05) were significantly higher in the day 2 embryo transfer group compared with day 3. On the other hand, implantation rates were not different between groups (23.9% vs. 17.2% , respectively; P = .08). Conclusion(s): Our results demonstrated that trans-fering embryos on day 2 could provide an alternative to the management of poor responder patients.
