Endometrial Heparin-binding Epidermal Growth Factor Expression in Implantation Window of Obese Women With Polycystic Ovarian Syndrome(PCOS)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Endometrial Heparin-binding Epidermal Growth Factor Expression
研究概览
简要总结
Women with PCOS comprise a majority of fertility clinic attendees. Unfortunately, a high failure rate following fertility treatment was observed especially in obese women due to implantation failure. The local study on PCOS women has shown significant changes in an endometrial tumor - regulatory genes but not focusing on the endometrial implantation failure. Many previous attempts using human chorionic gonadotrophin (HCG) infused embryo, gonadotrophin agonist therapy or progesterone support aiming to improve implantation failure in the assisted reproductive technique still unable to enhance pregnancy rate beyond 40% despite a higher' fertilization rate up to 95%. There is still a research gap on what makes obese PCOS women prone to coincides with implantation failure. Endometrial component related to the expression of growth factors play an integral role in establishing cellular context necessary for successful pregnancy. Thus, a new fundamental knowledge on endometrial specific heparin-binding epidermal growth factor expression in the obese PCOS women is vitally important, not only to predict implantation failure but a potential therapy to improve pregnancy outcome.
详细描述
This prospective study is going to be performed at UKM Medical Centre for a duration of 1 year. The PCOS and control women will be recruited from the Medically Assisted clinic in Obstetrics & Gynaecology department.
The sample size of this study is calculated using Power and Sample Size Calculator by Dupont & Plummer 1998 for paired t-test response version 3.1.2; using the endpoint of mean of Hb-EGF expression during window of implantation in predicting successful pregnancy following in vitro fertilization (IVF) rate by Mengling et al. 2016 (11) as one of its specific outcome. The auto-generated sample size using this programme is 8 subjects. Considering the dropout rate of the sample is 30%, the total sample size required in this study is 10 subjects each arm, making a total sample size 40.
The participants are divided into four groups according to PCOS diagnosis and Asian adult population body mass index (BMI):
- Anovulatory PCOS women with a BMI greater than 27 (OB-PCOS)
- Anovulatory PCOS women with a BMI lower than 25 (NW-PCOS)
- Healthy fertile women with a BMI greater than 27 (OB-C)
- Healthy fertile women with a BMI lower than 25 (NW-C)
In the PCOS group, generally anovulatory cycle hence the implantation window during mid-secretory endometrium can be exhibit following a daily oral micronized progesterone (Utrogestan 200mg) for 10 days based on previously published methods.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Anovulatory PCOS women with a BMI greater than 27
干预措施: utrogestan (Drug)
Anovulatory PCOS women with a BMI lower than 25
干预措施: utrogestan (Drug)
结局指标
主要结局
Endometrial Heparin-binding Epidermal Growth Factor Expression
时间窗: After 5 days of positive urinary LH
For obese and normal BMI normal fertile women window of implantation based on Noyes criteria
次要结局
- Hormonal assay(During day 2-6 of menstrual cycle)
研究者
Azrai Abu
Principal Investigator
National University of Malaysia