This Prospective Longitudinal Cohort Study Included Infertile Women With PCOS Unresponsive to Clomiphene Citrate Treatment, Who Underwent Either Unilateral (ULOD) or Bilateral (BLOD)Laparoscopic Diathermy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KBC Split
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Ovulation rate
研究概览
简要总结
The objective of our study was to compare the efficiency of the right ULOD using thermal doses adjusted to ovarian volume (60 J/cm3) with the BLOD method at constant dose and to assess treatment efficiency.
详细描述
The study included 96 infertile, clomiphene citrate-resistant women with polycystic ovary syndrome (PCOS), who underwent either unilateral or bilateral laparoscopic diathermy at the Clinical Hospital Split, Croatia. PCOS was diagnosed following the Rotterdam consensus criteria. In the ULOD group, we treated the right ovary with thermal dose of 60 J applied per one cubic centimeter of ovarian. In the comparator, BLOD group, all patients received 600 J per ovary. The follow-up period encompassed six menstrual cycles for all subjects.Sample size was based on the test of the primary hypothesis that ULOD treatment would result in a higher ovulation rate than BLOD. In our pilot study in 61 patients, ovulation rates were estimated to 44% in the BLOD arm and 69% in the ULOD arm. Assuming 5% significance and 80% power, we calculated that the minimal sample size for a one-sided test had to be 96 patients.
The aims of our prospective study:
- Compare the efficiency of the right ULOD using thermal doses adjusted to ovarian volume (60 J/cm3) with the BLOD method at constant dose and to assess treatment efficiency and predict ovulatory response based on clinical parameters (right or left ovary and its volume) and received thermal doses.
- Evidence the effects of ULOD using thermal doses adjusted to ovarian volume on endocrine (changes in androgen and AMH) and reproductive outcomes (ovulation rate) in clomiphene-resistant women with PCOS.
- To determine whether unilateral laparoscopic ovarian drilling (ULOD) using thermal doses adjusted to ovarian volume diminishes ovarian reserve less than bilateral LOD (BLOD) using a fixed thermal dose
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age between 25 and 35 years,
- •BMI<30 kg/m2,
- •infertility period 1-3 years,
- •normal partner's semen findings,
- •LH≥10 or LH:FSH ratio ≥2,
- •testosterone >2.5 nmol/L,
- •normal oral glucose tolerance test (OGTT).
排除标准
- •adrenal hyperplasia,
- •thyroid disease,
- •Cushing's syndrome,
- •hyperprolactinemia,
- •tumor-related androgen excess
结局指标
主要结局
Ovulation rate
时间窗: Six menstrual cycles after LOD for each women
The main output parameter study is the difference in the rate of ovulation after LOD between the groups with respect to the input parameters (anti-Müller hormone AMH \[ng / ml\], free androgen index (FAI), T \[nmol / L\],luteinizing hormone (LH) \[IU / L\], androstenedione A \[nmol / L\], the number of follicles in both ovaries (AFC), total ovarian volume \[cm3\], the volume of the right ovary \[cm3\], the volume of the left ovary \[cm3\] and received thermal doses)
次要结局
- Pregnancy(Six menstrual cycles after LOD for each women)