The Comparison of Reproductive Outcomes of Hsyteroscopic Metroplasty Versus Spontaneous Coitus Plus COH/IUI Cycles in Unexplained Infertile Women With Dysmorphic Uterus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- clinical pregnancy rate (CPR)
研究概览
简要总结
The correlation between dysmorphic uterus and infertility still remains enigmatic. We aim to evaluate the reproductive outcomes of metroplasty via office hysteroscopy in unexplained infertile women with dysmorphic uterus with comparing a group of unexplained infertile women performing 6 months spontaneous cycles plus 3 cycles controlled ovarian hyperstimulation and intrauterine insemination by randomized trial.
详细描述
A dysmorphic uterus is a second-class (Class U1) uterine anomaly in the The European Society of Human Reproduction and Embryology (ESHRE) and the European Society for Gynaecological Endoscopy (ESGE) (ESHRE/ESGE) consensus on the classification of congenital genital tract anomalies, which was formerly known as "T-shaped uterus" in the American Fertility Society (AFS) Classification of Anomalies of the Müllerian Duct that leads to poor reproductive and obstetric outcomes.
The reproductive performance of dysmorphic uterus is not well-known issue. We designed a randomized trial in unexplained infertile couples women with dysmorphic uterus. After allocation of properly selected women, hysteroscopy group will be undertaken metroplasty procedure and 9 months follow-up period with natural conception. Second group will be undertaken to six months spontaneous coitus and three cycles clomiphene citrate and intrauterine insemination cycles. After nine months of follow-up of both groups, the pregnancy and reproductive outcomes will be evaluated.
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
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Unexplained infertile couples with;
- •Dysmorpic uterus in hysterosalpingography
- •Normal spermiogram
- •Bilateral patent tubes in hysterosalpingography
- •Normal ovarian reserve (AMH >1.5 ng/dl and/or total bilateral antral follicle count >8)
排除标准
- •Women with history of pelvic surgery including endometriosis and/or tubal surgery
- •women with endometrioma which was visualised/suspected on transvaginal ultrasonography
- •Women with anovulation
- •Women with diminished ovarian reserve (AMH < 1.5 ng/dl and/or total bilateral antral follicle count <8)
- •Couples with abnormal spermiogram parameters (oligospermia, oligoasthenospermia, oligoasthenoteratozoospermia, azospermia)
- •Women with alive children
- •Obese women (BMI>30 kg/m2)
研究组 & 干预措施
Intervention arm: Hysterocopy group
Office hyteroscopic metroplasty will be performed. After oparetion 9 months spontaneous conception Intervention arm for hysteroscopy group
干预措施: office hysteroscopic metroplasty intervention arm (Procedure)
Spontaneous cycles plus COH/IUI
Six months spontaneous coitus cycles plus 3 cycles of Clomiphene citrate and intrauterine insemination (COH/IUI)
结局指标
主要结局
clinical pregnancy rate (CPR)
时间窗: 9 months
Intrauterine gestational sac with viable fetal heart rate
次要结局
- ectopic pregnancy rate(10 weeks)
- abortion(10 weeks)
研究者
Bulent Haydardedeoglu
Associate Prof. M.D.
Baskent University